{
    "info": {
        "nct_id": "NCT00002631",
        "official_title": "A PHASE III INTERGROUP RANDOMIZED COMPARISON OF COMBINED MODALITY THERAPY FOR CARCINOMA OF THE ESOPHAGUS: HIGH-DOSE VS CONVENTIONAL-DOSE RADIATION THERAPY",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Biopsy-proven primary squamous cell or adenocarcinoma of the esophagus Clinical Stage T1-4, Nx, M0 disease required Disease entirely confined to the esophagus and periesophageal soft tissue with no tumor extension within 2 cm proximal to the stomach No biopsy-proven invasion of the tracheal-bronchial tree or tracheal-esophageal (TE) fistula Bronchoscopy of tracheal-bronchial tree required for lesions less than 30 cm from the incisors to exclude TE fistula Negative liver biopsy required if liver CT suggestive of metastatic disease Negative biopsy required for enlarged (1.5 cm or greater) retroperitoneal or celiac nodes seen on CT Negative biopsy of clinically or radiographically positive supraclavicular nodes required with cervical primaries No recurrent disease No multiple carcinomas of the esophagus\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100% Hematopoietic: WBC at least 4,000 Platelets at least 150,000 Hb at least 10 g/dL Hepatic: Not specified Renal: Creatinine normal OR Creatinine clearance at least 65 mL/min Nutrition: Recommended oral intake requirements (by mouth or tube feeding): More than 1.5 x Basal Energy Expenditure (BEE) measured by Harris- Benedict equation OR More than 1,000 calories/sqm of body surface area (BSA) Intravenous hyperalimentation (recommended if inadequate oral intake): 1.75-2.25 x BEE OR 1,200-1,600 calories/sqm BSA Upper limits may be waived for hypermetabolic patients Other: No second malignancy within 5 years except: Curable nonmelanomatous skin cancer Cervical cancer in situ No pregnant or nursing women\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent growth factor administration Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior chest irradiation Surgery: No prior resection"
    },
    "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 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: Biopsy-proven primary squamous cell or adenocarcinoma of the esophagus Clinical Stage T1-4, Nx, M0 disease required Disease entirely confined to the esophagus and periesophageal soft tissue with no tumor extension within 2 cm proximal to the stomach No biopsy-proven invasion of the tracheal-bronchial tree or tracheal-esophageal (TE) fistula Bronchoscopy of tracheal-bronchial tree required for lesions less than 30 cm from the incisors to exclude TE fistula Negative liver biopsy required if liver CT suggestive of metastatic disease Negative biopsy required for enlarged (1.5 cm or greater) retroperitoneal or celiac nodes seen on CT Negative biopsy of clinically or radiographically positive supraclavicular nodes required with cervical primaries No recurrent disease No multiple carcinomas of the esophagus",
            "criterions": [
                {
                    "exact_snippets": "Biopsy-proven primary squamous cell or adenocarcinoma of the esophagus",
                    "criterion": "primary squamous cell or adenocarcinoma of the esophagus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical Stage T1-4, Nx, M0 disease required",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T1",
                                "T2",
                                "T3",
                                "T4"
                            ]
                        },
                        {
                            "requirement_type": "node involvement",
                            "expected_value": "Nx"
                        },
                        {
                            "requirement_type": "metastasis",
                            "expected_value": "M0"
                        }
                    ]
                },
                {
                    "exact_snippets": "Disease entirely confined to the esophagus and periesophageal soft tissue",
                    "criterion": "disease location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "esophagus and periesophageal soft tissue"
                        }
                    ]
                },
                {
                    "exact_snippets": "no tumor extension within 2 cm proximal to the stomach",
                    "criterion": "tumor extension",
                    "requirements": [
                        {
                            "requirement_type": "distance from stomach",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No biopsy-proven invasion of the tracheal-bronchial tree",
                    "criterion": "invasion of the tracheal-bronchial tree",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... tracheal-esophageal (TE) fistula",
                    "criterion": "tracheal-esophageal (TE) fistula",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Bronchoscopy of tracheal-bronchial tree required for lesions less than 30 cm from the incisors",
                    "criterion": "bronchoscopy requirement",
                    "requirements": [
                        {
                            "requirement_type": "lesion distance from incisors",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Negative liver biopsy required if liver CT suggestive of metastatic disease",
                    "criterion": "liver biopsy",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Negative biopsy required for enlarged (1.5 cm or greater) retroperitoneal or celiac nodes seen on CT",
                    "criterion": "retroperitoneal or celiac nodes biopsy",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "node size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Negative biopsy of clinically or radiographically positive supraclavicular nodes required with cervical primaries",
                    "criterion": "supraclavicular nodes biopsy",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "No recurrent disease",
                    "criterion": "recurrent disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No multiple carcinomas of the esophagus",
                    "criterion": "multiple carcinomas of the esophagus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent growth factor administration Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior chest irradiation Surgery: No prior resection",
            "criterions": [
                {
                    "exact_snippets": "No prior or concurrent growth factor administration",
                    "criterion": "growth factor administration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior chest irradiation",
                    "criterion": "chest irradiation",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior resection",
                    "criterion": "resection",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100% Hematopoietic: WBC at least 4,000 Platelets at least 150,000 Hb at least 10 g/dL Hepatic: Not specified Renal: Creatinine normal OR Creatinine clearance at least 65 mL/min Nutrition: Recommended oral intake requirements (by mouth or tube feeding): More than 1.5 x Basal Energy Expenditure (BEE) measured by Harris- Benedict equation OR More than 1,000 calories/sqm of body surface area (BSA) Intravenous hyperalimentation (recommended if inadequate oral intake): 1.75-2.25 x BEE OR 1,200-1,600 calories/sqm BSA Upper limits may be waived for hypermetabolic patients Other: No second malignancy within 5 years except: Curable nonmelanomatous skin cancer Cervical cancer in situ No pregnant or nursing women",
            "criterions": [
                {
                    "exact_snippets": "Age: 18 and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: Karnofsky 60%-100%",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "Karnofsky score",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 60,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: WBC at least 4,000",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "minimum count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4000,
                                "unit": "cells/µL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: ... Platelets at least 150,000",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "minimum count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 150000,
                                "unit": "cells/µL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: ... Hb at least 10 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "minimum level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal: Creatinine normal OR Creatinine clearance at least 65 mL/min",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "creatinine level",
                            "expected_value": "normal"
                        },
                        {
                            "requirement_type": "creatinine clearance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 65,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Nutrition: Recommended oral intake requirements ... More than 1.5 x Basal Energy Expenditure (BEE) measured by Harris- Benedict equation OR More than 1,000 calories/sqm of body surface area (BSA)",
                    "criterion": "oral intake",
                    "requirements": [
                        {
                            "requirement_type": "energy intake",
                            "expected_value": [
                                "> 1.5 x BEE",
                                " > 1,000 calories/sqm BSA"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Intravenous hyperalimentation ... 1.75-2.25 x BEE OR 1,200-1,600 calories/sqm BSA",
                    "criterion": "intravenous hyperalimentation",
                    "requirements": [
                        {
                            "requirement_type": "energy intake",
                            "expected_value": [
                                "1.75-2.25 x BEE",
                                "1,200-1,600 calories/sqm BSA"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: No second malignancy within 5 years except: Curable nonmelanomatous skin cancer Cervical cancer in situ",
                    "criterion": "second malignancy",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "Curable nonmelanomatous skin cancer",
                                "Cervical cancer in situ"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: No pregnant or nursing women",
                    "criterion": "pregnancy or nursing status",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ]
}