{
    "info": {
        "nct_id": "NCT00331760",
        "official_title": "A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Must have undergone a hysterectomy (total abdominal, vaginal, radical, or laparoscopic-assisted vaginal) within 7 weeks prior to study entry\n\n  * Patients with endometrial cancer must have also undergone a bilateral salpingo-oophorectomy\n* Histologically confirmed diagnosis of 1 of the following:\n\n  * Endometrial cancer meeting 1 of the following criteria:\n\n    * Stage IB grade 3, IC grade 1-3, IIA, or IIB disease requiring postoperative pelvic radiotherapy\n    * Unstaged (no lymph node dissection or sampling) stage IB grade 2 disease\n    * Stage IIIC with all of the following:\n\n      * Pelvic lymph node positive only\n      * Para-aortic nodes sampled negative\n      * Not receiving chemotherapy\n  * Cervical cancer meeting 1 of the following criteria:\n\n    * Post-radical hysterectomy and requires postoperative pelvic radiotherapy due to any of the following:\n\n      * Positive pelvic nodes (negative para-aortic nodes)\n      * Microscopic parametrial involvement and negative margins\n      * Disease qualified by Sedlis criteria must have 2 of the following risk factors:\n\n        * 1/3 or more stromal invasion\n        * Lymph-vascular space invasion\n        * Large clinical tumor diameter (≥ 4 cm)\n    * Post-simple hysterectomy with negative margins and negative nodes by CT scan, MRI, or positron emission tomography-CT scan\n* No requirement for extended-field radiotherapy beyond the pelvis\n* No histologically confirmed papillary serous, clear cell, or neuroendocrine (either large or small cell) disease, endometrial stromal sarcoma, leiomyosarcoma, or malignant müllerian mixed tumor\n* No evidence of metastatic disease outside of the pelvis\n* No microscopic involvement of the resection margin (< 3 mm)\n\nPATIENT CHARACTERISTICS:\n\n* Zubrod performance status 0-2\n* WBC (white blood cell count) ≥ 4,000/mm³ (cervical cancer patients only)\n* Absolute neutrophil count ≥ 1,800/mm³ (cervical cancer patients only)\n* Platelet count ≥ 100,000/mm³ (cervical cancer patients only)\n* Hemoglobin ≥ 8.0 g/dL (transfusion allowed)\n* Serum creatinine ≤ 2.0 mg/dL (cervical cancer patients only)\n* Creatinine clearance ≥ 50 mL/min (cervical cancer patients only)\n* AST (aspartate aminotransferase) ≤ 2 times upper limit of normal\n* Bilirubin ≤ 2 times upper limit of normal\n* Patients must not exceed the weight and size limits of the treatment table or CT scanner\n\n  * No mental status changes or bladder control problems that would preclude study compliance with bladder-filling instructions\n* No active inflammatory bowel disease\n* No severe, active, concurrent illness, defined as any of the following:\n\n  * Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months\n  * Transmural myocardial infarction within the past 6 months\n  * Acute bacterial or fungal infection requiring IV antibiotics\n  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy\n  * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects\n  * AIDS\n* No history of allergy to cisplatin (cervical cancer patients)\n* No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for ≥ 3 years\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields\n* No prior platinum-based chemotherapy (cervical cancer patients)\n* No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or pegfilgrastim)\n* No concurrent prophylactic thrombopoietic agents\n* No concurrent amifostine or other protective agents"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have undergone a hysterectomy (total abdominal, vaginal, radical, or laparoscopic-assisted vaginal) within 7 weeks prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "Must have undergone a hysterectomy (total abdominal, vaginal, radical, or laparoscopic-assisted vaginal)",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "total abdominal",
                                "vaginal",
                                "radical",
                                "laparoscopic-assisted vaginal"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 weeks prior to study entry",
                    "criterion": "time since hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with endometrial cancer must have also undergone a bilateral salpingo-oophorectomy",
            "criterions": [
                {
                    "exact_snippets": "Patients with endometrial cancer",
                    "criterion": "endometrial cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have also undergone a bilateral salpingo-oophorectomy",
                    "criterion": "bilateral salpingo-oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": "completed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed diagnosis of 1 of the following:",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed diagnosis",
                    "criterion": "diagnosis confirmation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "histologically"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Endometrial cancer meeting 1 of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Endometrial cancer",
                    "criterion": "endometrial cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage IB grade 3, IC grade 1-3, IIA, or IIB disease requiring postoperative pelvic radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Stage IB grade 3",
                    "criterion": "disease stage and grade",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IB"
                        },
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "IC grade 1-3",
                    "criterion": "disease stage and grade",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IC"
                        },
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "IIA",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IIA"
                        }
                    ]
                },
                {
                    "exact_snippets": "IIB",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IIB"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring postoperative pelvic radiotherapy",
                    "criterion": "postoperative pelvic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unstaged (no lymph node dissection or sampling) stage IB grade 2 disease",
            "criterions": [
                {
                    "exact_snippets": "Unstaged (no lymph node dissection or sampling)",
                    "criterion": "lymph node dissection or sampling",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "stage IB",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "IB"
                        }
                    ]
                },
                {
                    "exact_snippets": "grade 2 disease",
                    "criterion": "cancer grade",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "2"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage IIIC with all of the following:",
            "criterions": [
                {
                    "exact_snippets": "Stage IIIC",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IIIC"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pelvic lymph node positive only",
            "criterions": [
                {
                    "exact_snippets": "Pelvic lymph node positive",
                    "criterion": "pelvic lymph node",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Para-aortic nodes sampled negative",
            "criterions": [
                {
                    "exact_snippets": "Para-aortic nodes sampled negative",
                    "criterion": "para-aortic nodes",
                    "requirements": [
                        {
                            "requirement_type": "sampled",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not receiving chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Not receiving chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cervical cancer meeting 1 of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Cervical cancer",
                    "criterion": "cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Post-radical hysterectomy and requires postoperative pelvic radiotherapy due to any of the following:",
            "criterions": [
                {
                    "exact_snippets": "Post-radical hysterectomy",
                    "criterion": "radical hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requires postoperative pelvic radiotherapy",
                    "criterion": "postoperative pelvic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Positive pelvic nodes (negative para-aortic nodes)",
            "criterions": [
                {
                    "exact_snippets": "Positive pelvic nodes",
                    "criterion": "pelvic nodes",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative para-aortic nodes",
                    "criterion": "para-aortic nodes",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Microscopic parametrial involvement and negative margins",
            "criterions": [
                {
                    "exact_snippets": "Microscopic parametrial involvement",
                    "criterion": "parametrial involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "extent",
                            "expected_value": "microscopic"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative margins",
                    "criterion": "margins",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease qualified by Sedlis criteria must have 2 of the following risk factors:",
            "criterions": [
                {
                    "exact_snippets": "Disease qualified by Sedlis criteria",
                    "criterion": "disease qualification",
                    "requirements": [
                        {
                            "requirement_type": "qualification",
                            "expected_value": "Sedlis criteria"
                        }
                    ]
                },
                {
                    "exact_snippets": "must have 2 of the following risk factors",
                    "criterion": "risk factors",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "risk factors"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 1/3 or more stromal invasion",
            "criterions": [
                {
                    "exact_snippets": "1/3 or more stromal invasion",
                    "criterion": "stromal invasion",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "third"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lymph-vascular space invasion",
            "criterions": [
                {
                    "exact_snippets": "Lymph-vascular space invasion",
                    "criterion": "lymph-vascular space invasion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Large clinical tumor diameter (≥ 4 cm)",
            "criterions": [
                {
                    "exact_snippets": "Large clinical tumor diameter (≥ 4 cm)",
                    "criterion": "clinical tumor diameter",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Post-simple hysterectomy with negative margins and negative nodes by CT scan, MRI, or positron emission tomography-CT scan",
            "criterions": [
                {
                    "exact_snippets": "Post-simple hysterectomy",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "simple"
                        },
                        {
                            "requirement_type": "post-surgery status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative margins",
                    "criterion": "margins",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative nodes by CT scan, MRI, or positron emission tomography-CT scan",
                    "criterion": "nodes",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "detection method",
                            "expected_value": [
                                "CT scan",
                                "MRI",
                                "positron emission tomography-CT scan"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No requirement for extended-field radiotherapy beyond the pelvis",
            "criterions": [
                {
                    "exact_snippets": "No requirement for extended-field radiotherapy beyond the pelvis",
                    "criterion": "extended-field radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "pelvis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No histologically confirmed papillary serous, clear cell, or neuroendocrine (either large or small cell) disease, endometrial stromal sarcoma, leiomyosarcoma, or malignant müllerian mixed tumor",
            "criterions": [
                {
                    "exact_snippets": "No histologically confirmed papillary serous",
                    "criterion": "papillary serous disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No histologically confirmed ... clear cell",
                    "criterion": "clear cell disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No histologically confirmed ... neuroendocrine (either large or small cell)",
                    "criterion": "neuroendocrine disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No histologically confirmed ... endometrial stromal sarcoma",
                    "criterion": "endometrial stromal sarcoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No histologically confirmed ... leiomyosarcoma",
                    "criterion": "leiomyosarcoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No histologically confirmed ... malignant müllerian mixed tumor",
                    "criterion": "malignant müllerian mixed tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of metastatic disease outside of the pelvis",
            "criterions": [
                {
                    "exact_snippets": "No evidence of metastatic disease outside of the pelvis",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "pelvis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No microscopic involvement of the resection margin (< 3 mm)",
            "criterions": [
                {
                    "exact_snippets": "No microscopic involvement of the resection margin (< 3 mm)",
                    "criterion": "microscopic involvement of the resection margin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Zubrod performance status 0-2",
            "criterions": [
                {
                    "exact_snippets": "Zubrod performance status 0-2",
                    "criterion": "Zubrod performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WBC (white blood cell count) ≥ 4,000/mm³ (cervical cancer patients only)",
            "criterions": [
                {
                    "exact_snippets": "WBC (white blood cell count) ≥ 4,000/mm³",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4000,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1,800/mm³ (cervical cancer patients only)",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1,800/mm³",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1800,
                                "unit": "mm³"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical cancer patients only",
                    "criterion": "cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥ 100,000/mm³ (cervical cancer patients only)",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100,000/mm³",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm³"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical cancer patients only",
                    "criterion": "cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 8.0 g/dL (transfusion allowed)",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 8.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "transfusion allowed",
                    "criterion": "transfusion",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine ≤ 2.0 mg/dL (cervical cancer patients only)",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤ 2.0 mg/dL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical cancer patients only",
                    "criterion": "cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine clearance ≥ 50 mL/min (cervical cancer patients only)",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance ≥ 50 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical cancer patients only",
                    "criterion": "cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST (aspartate aminotransferase) ≤ 2 times upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "AST (aspartate aminotransferase) ≤ 2 times upper limit of normal",
                    "criterion": "AST (aspartate aminotransferase)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin ≤ 2 times upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin ≤ 2 times upper limit of normal",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must not exceed the weight and size limits of the treatment table or CT scanner",
            "criterions": [
                {
                    "exact_snippets": "weight ... limits of the treatment table or CT scanner",
                    "criterion": "weight",
                    "requirements": [
                        {
                            "requirement_type": "limit",
                            "expected_value": "not exceed"
                        }
                    ]
                },
                {
                    "exact_snippets": "size limits of the treatment table or CT scanner",
                    "criterion": "size",
                    "requirements": [
                        {
                            "requirement_type": "limit",
                            "expected_value": "not exceed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No mental status changes or bladder control problems that would preclude study compliance with bladder-filling instructions",
            "criterions": [
                {
                    "exact_snippets": "No mental status changes",
                    "criterion": "mental status changes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... bladder control problems",
                    "criterion": "bladder control problems",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active inflammatory bowel disease",
            "criterions": [
                {
                    "exact_snippets": "No active inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No severe, active, concurrent illness, defined as any of the following:",
            "criterions": [
                {
                    "exact_snippets": "severe, active, concurrent illness",
                    "criterion": "concurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "not active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "Unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure requiring hospitalization within the past 6 months",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "hospitalization",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Transmural myocardial infarction within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "Transmural myocardial infarction within the past 6 months",
                    "criterion": "transmural myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute bacterial or fungal infection requiring IV antibiotics",
            "criterions": [
                {
                    "exact_snippets": "Acute bacterial or fungal infection",
                    "criterion": "infection type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "bacterial",
                                "fungal"
                            ]
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "acute"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring IV antibiotics",
                    "criterion": "treatment requirement",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "IV antibiotics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy",
            "criterions": [
                {
                    "exact_snippets": "Chronic obstructive pulmonary disease exacerbation",
                    "criterion": "chronic obstructive pulmonary disease exacerbation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other respiratory illness requiring hospitalization",
                    "criterion": "respiratory illness",
                    "requirements": [
                        {
                            "requirement_type": "hospitalization",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other respiratory illness ... precluding study therapy",
                    "criterion": "respiratory illness",
                    "requirements": [
                        {
                            "requirement_type": "preclusion of study therapy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects",
            "criterions": [
                {
                    "exact_snippets": "Hepatic insufficiency resulting in clinical jaundice",
                    "criterion": "hepatic insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "resulting condition",
                            "expected_value": "clinical jaundice"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic insufficiency resulting in ... coagulation defects",
                    "criterion": "hepatic insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "resulting condition",
                            "expected_value": "coagulation defects"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AIDS",
            "criterions": [
                {
                    "exact_snippets": "AIDS",
                    "criterion": "AIDS",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of allergy to cisplatin (cervical cancer patients)",
            "criterions": [
                {
                    "exact_snippets": "No history of allergy to cisplatin",
                    "criterion": "allergy to cisplatin",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for ≥ 3 years",
            "criterions": [
                {
                    "exact_snippets": "No prior invasive malignancy (except nonmelanoma skin cancer)",
                    "criterion": "prior invasive malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unless disease-free for ≥ 3 years",
                    "criterion": "disease-free period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "See Disease Characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields",
            "criterions": [
                {
                    "exact_snippets": "No prior radiotherapy to the pelvis",
                    "criterion": "prior radiotherapy to the pelvis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "overlap of radiotherapy fields",
                    "criterion": "overlap of radiotherapy fields",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior platinum-based chemotherapy (cervical cancer patients)",
            "criterions": [
                {
                    "exact_snippets": "No prior platinum-based chemotherapy (cervical cancer patients)",
                    "criterion": "prior platinum-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or pegfilgrastim)",
            "criterions": [
                {
                    "exact_snippets": "No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or pegfilgrastim)",
                    "criterion": "concurrent prophylactic growth factors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent prophylactic thrombopoietic agents",
            "criterions": [
                {
                    "exact_snippets": "No concurrent prophylactic thrombopoietic agents",
                    "criterion": "concurrent prophylactic thrombopoietic agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent amifostine or other protective agents",
            "criterions": [
                {
                    "exact_snippets": "No concurrent amifostine",
                    "criterion": "amifostine",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent ... other protective agents",
                    "criterion": "other protective agents",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        }
    ]
}