{
"info": {
"nct_id": "NCT02875457",
"official_title": "A Randomized Controlled Study of Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide and Cisplatin Chemotherapy",
"inclusion_criteria": "* Histologic or cytologic diagnosis of small cell lung caner(SCLC), Extensive Stage.\n* No prior cisplatin-based chemotherapy or radiotherapy.\n* Males or females between 18 Years to 75 Years.\n* Performance status of 0~2 on the ECOG criteria.\n* Expected survival is above three months.\n* At least one measurable lung tumor lesion (according to RECIST criteria, the application of conventional technology, diameter length of the lesion >= 20mm or spiral CT >=10mm).\n* Adequate hematologic (Leukocyte count >= 4.0×109/L, neutrophil count>=2.0×109/L, hemoglobin>=95g/L, platelets>=100×109/L), hepatic function (aspartate transaminase (AST) & alanine transaminase(ALT) =<upper normal limit(UNL) x1.5, bilirubin level =< UNL x 1.5).\n* Patient can take oral medicine.\n* Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* History of cardiovascular disease: congestive heart failure (CHF) > New York Heart Association (NYHA) II, active coronary artery disease(patients with myocardial infarction six months ago can be recruited), arrhythmias need to be treated (allow taking beta blockers or digoxin).\n* Serious clinical infection (> NCI-CTCAE version 4.0 ,infection standard II).\n* Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).\n* with brain metastases.\n* The patients had accepted allogeneic organ transplantation.\n* Bleeding tendency or coagulation disorders.\n* patients who need renal dialysis.\n* suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor).\n* uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 90 mmHg).\n* thrombosis or embolism(cerebrovascular accidents including transient ischemic attack within the last 6 months).\n* pulmonary hemorrhage >CTCAE grade 2 within 4 weeks before first use of drugs.\n* Other organ hemorrhage >CTCAE grade 3 within 4 weeks before first use of drugs.\n* severe uncured wounds, ulcers or fracture.\n* uncured dehydration.\n* Drugs abuse and medical, psychological or social conditions may interfere with the patient's participation in research or the results of the evaluation effect.\n* Patients are allergic to drugs used in research.\n* Factors influencing the safety and compliance of patients.\n* Inability to comply with protocol or study procedures.\n* Pregnant or breast-feeding.\n* The researcher believe that the Patient is not suitable to participate in the study.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Histologic or cytologic diagnosis of small cell lung caner(SCLC), Extensive Stage.",
"criterions": [
{
"exact_snippets": "Histologic or cytologic diagnosis of small cell lung caner(SCLC)",
"criterion": "small cell lung cancer (SCLC)",
"requirements": [
{
"requirement_type": "diagnosis method",
"expected_value": [
"histologic",
"cytologic"
]
}
]
},
{
"exact_snippets": "Extensive Stage",
"criterion": "small cell lung cancer (SCLC)",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "Extensive"
}
]
}
]
},
{
"line": "* No prior cisplatin-based chemotherapy or radiotherapy.",
"criterions": [
{
"exact_snippets": "No prior cisplatin-based chemotherapy",
"criterion": "prior cisplatin-based chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No prior ... radiotherapy",
"criterion": "prior radiotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Males or females between 18 Years to 75 Years.",
"criterions": [
{
"exact_snippets": "Males or females",
"criterion": "gender",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"male",
"female"
]
}
]
},
{
"exact_snippets": "between 18 Years to 75 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "Years"
},
{
"operator": "<=",
"value": 75,
"unit": "Years"
}
]
}
}
]
}
]
},
{
"line": "* Performance status of 0~2 on the ECOG criteria.",
"criterions": [
{
"exact_snippets": "Performance status of 0~2 on the ECOG criteria.",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* Expected survival is above three months.",
"criterions": [
{
"exact_snippets": "Expected survival is above three months.",
"criterion": "expected survival",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
}
]
}
]
},
{
"line": "* At least one measurable lung tumor lesion (according to RECIST criteria, the application of conventional technology, diameter length of the lesion >= 20mm or spiral CT >=10mm).",
"criterions": [
{
"exact_snippets": "measurable lung tumor lesion",
"criterion": "lung tumor lesion",
"requirements": [
{
"requirement_type": "measurability",
"expected_value": true
}
]
},
{
"exact_snippets": "diameter length of the lesion >= 20mm",
"criterion": "lung tumor lesion diameter",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "mm"
}
}
]
},
{
"exact_snippets": "spiral CT >=10mm",
"criterion": "lung tumor lesion diameter (spiral CT)",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "mm"
}
}
]
}
]
},
{
"line": "* Adequate hematologic (Leukocyte count >= 4.0×109/L, neutrophil count>=2.0×109/L, hemoglobin>=95g/L, platelets>=100×109/L), hepatic function (aspartate transaminase (AST) & alanine transaminase(ALT) =<upper normal limit(UNL) x1.5, bilirubin level =< UNL x 1.5).",
"criterions": [
{
"exact_snippets": "Leukocyte count >= 4.0×109/L",
"criterion": "leukocyte count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 4.0,
"unit": "×10^9/L"
}
}
]
},
{
"exact_snippets": "neutrophil count>=2.0×109/L",
"criterion": "neutrophil count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2.0,
"unit": "×10^9/L"
}
}
]
},
{
"exact_snippets": "hemoglobin>=95g/L",
"criterion": "hemoglobin",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 95,
"unit": "g/L"
}
}
]
},
{
"exact_snippets": "platelets>=100×109/L",
"criterion": "platelet count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "×10^9/L"
}
}
]
},
{
"exact_snippets": "aspartate transaminase (AST) ... =<upper normal limit(UNL) x1.5",
"criterion": "aspartate transaminase (AST)",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "UNL"
}
}
]
},
{
"exact_snippets": "alanine transaminase(ALT) =<upper normal limit(UNL) x1.5",
"criterion": "alanine transaminase (ALT)",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "UNL"
}
}
]
},
{
"exact_snippets": "bilirubin level =< UNL x 1.5",
"criterion": "bilirubin level",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "UNL"
}
}
]
}
]
},
{
"line": "* Patient can take oral medicine.",
"criterions": [
{
"exact_snippets": "Patient can take oral medicine.",
"criterion": "ability to take oral medicine",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.",
"criterions": [
{
"exact_snippets": "ability to understand and voluntarily sign the informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "allow adequate follow-up",
"criterion": "follow-up",
"requirements": [
{
"requirement_type": "allowance",
"expected_value": true
}
]
}
]
},
{
"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"
}
}
]
}
]
},
{
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* History of cardiovascular disease: congestive heart failure (CHF) > New York Heart Association (NYHA) II, active coronary artery disease(patients with myocardial infarction six months ago can be recruited), arrhythmias need to be treated (allow taking beta blockers or digoxin).",
"criterions": [
{
"exact_snippets": "History of cardiovascular disease: congestive heart failure (CHF) > New York Heart Association (NYHA) II",
"criterion": "congestive heart failure (CHF)",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "New York Heart Association (NYHA)"
}
}
]
},
{
"exact_snippets": "History of cardiovascular disease: ... active coronary artery disease",
"criterion": "active coronary artery disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "History of cardiovascular disease: ... arrhythmias need to be treated",
"criterion": "arrhythmias",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": true
}
]
}
]
},
{
"line": "* Serious clinical infection (> NCI-CTCAE version 4.0 ,infection standard II).",
"criterions": [
{
"exact_snippets": "Serious clinical infection (> NCI-CTCAE version 4.0 ,infection standard II)",
"criterion": "clinical infection",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "serious"
},
{
"requirement_type": "NCI-CTCAE version",
"expected_value": "> 4.0"
},
{
"requirement_type": "infection standard",
"expected_value": "II"
}
]
}
]
},
{
"line": "* Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).",
"criterions": [
{
"exact_snippets": "Patients with epilepsy",
"criterion": "epilepsy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "need to take medicine (such as steroids or anti epilepsy agents)",
"criterion": "medicine requirement",
"requirements": [
{
"requirement_type": "types",
"expected_value": [
"steroids",
"anti epilepsy agents"
]
}
]
}
]
},
{
"line": "* with brain metastases.",
"criterions": [
{
"exact_snippets": "brain metastases",
"criterion": "brain metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* The patients had accepted allogeneic organ transplantation.",
"criterions": [
{
"exact_snippets": "accepted allogeneic organ transplantation",
"criterion": "allogeneic organ transplantation",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Bleeding tendency or coagulation disorders.",
"criterions": [
{
"exact_snippets": "Bleeding tendency",
"criterion": "bleeding tendency",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "coagulation disorders",
"criterion": "coagulation disorders",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* patients who need renal dialysis.",
"criterions": [
{
"exact_snippets": "patients who need renal dialysis",
"criterion": "renal dialysis",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
}
]
},
{
"line": "* suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor).",
"criterions": [
{
"exact_snippets": "suffered from other tumor within 5 years",
"criterion": "other tumor",
"requirements": [
{
"requirement_type": "time since last occurrence",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "years"
}
}
]
},
{
"exact_snippets": "cervical carcinoma in situ",
"criterion": "cervical carcinoma in situ",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": true
}
]
},
{
"exact_snippets": "cured basal cell carcinoma",
"criterion": "cured basal cell carcinoma",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": true
}
]
},
{
"exact_snippets": "cured bladder epithelial tumor",
"criterion": "cured bladder epithelial tumor",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": true
}
]
}
]
},
{
"line": "* uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 90 mmHg).",
"criterions": [
{
"exact_snippets": "uncontrolled hypertension",
"criterion": "hypertension",
"requirements": [
{
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
]
},
{
"exact_snippets": "systolic pressure>150 mmHg",
"criterion": "systolic blood pressure",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 150,
"unit": "mmHg"
}
}
]
},
{
"exact_snippets": "diastolic pressure> 90 mmHg",
"criterion": "diastolic blood pressure",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 90,
"unit": "mmHg"
}
}
]
}
]
},
{
"line": "* thrombosis or embolism(cerebrovascular accidents including transient ischemic attack within the last 6 months).",
"criterions": [
{
"exact_snippets": "thrombosis",
"criterion": "thrombosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "embolism",
"criterion": "embolism",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "cerebrovascular accidents",
"criterion": "cerebrovascular accidents",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "transient ischemic attack within the last 6 months",
"criterion": "transient ischemic attack",
"requirements": [
{
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "* pulmonary hemorrhage >CTCAE grade 2 within 4 weeks before first use of drugs.",
"criterions": [
{
"exact_snippets": "pulmonary hemorrhage >CTCAE grade 2 within 4 weeks before first use of drugs.",
"criterion": "pulmonary hemorrhage",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "CTCAE grade"
}
},
{
"requirement_type": "time frame",
"expected_value": "within 4 weeks before first use of drugs"
}
]
}
]
},
{
"line": "* Other organ hemorrhage >CTCAE grade 3 within 4 weeks before first use of drugs.",
"criterions": [
{
"exact_snippets": "Other organ hemorrhage >CTCAE grade 3 within 4 weeks before first use of drugs.",
"criterion": "other organ hemorrhage",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "CTCAE grade"
}
},
{
"requirement_type": "time frame",
"expected_value": "within 4 weeks before first use of drugs"
}
]
}
]
},
{
"line": "* severe uncured wounds, ulcers or fracture.",
"criterions": [
{
"exact_snippets": "severe uncured wounds",
"criterion": "wounds",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
},
{
"requirement_type": "healing status",
"expected_value": "uncured"
}
]
},
{
"exact_snippets": "severe uncured ... ulcers",
"criterion": "ulcers",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
},
{
"requirement_type": "healing status",
"expected_value": "uncured"
}
]
},
{
"exact_snippets": "severe uncured ... fracture",
"criterion": "fracture",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
},
{
"requirement_type": "healing status",
"expected_value": "uncured"
}
]
}
]
},
{
"line": "* uncured dehydration.",
"criterions": [
{
"exact_snippets": "uncured dehydration",
"criterion": "dehydration",
"requirements": [
{
"requirement_type": "status",
"expected_value": "uncured"
}
]
}
]
},
{
"line": "* Drugs abuse and medical, psychological or social conditions may interfere with the patient's participation in research or the results of the evaluation effect.",
"criterions": [
{
"exact_snippets": "Drugs abuse",
"criterion": "drug abuse",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "medical, psychological or social conditions",
"criterion": "medical, psychological or social conditions",
"requirements": [
{
"requirement_type": "interference with participation",
"expected_value": false
}
]
}
]
},
{
"line": "* Patients are allergic to drugs used in research.",
"criterions": [
{
"exact_snippets": "Patients are allergic to drugs used in research.",
"criterion": "allergy to research drugs",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Factors influencing the safety and compliance of patients.",
"criterions": [
{
"exact_snippets": "Factors influencing the safety",
"criterion": "safety",
"requirements": [
{
"requirement_type": "influence",
"expected_value": "factors"
}
]
},
{
"exact_snippets": "Factors influencing the ... compliance of patients",
"criterion": "compliance",
"requirements": [
{
"requirement_type": "influence",
"expected_value": "factors"
}
]
}
]
},
{
"line": "* Inability to comply with protocol or study procedures.",
"criterions": [
{
"exact_snippets": "Inability to comply with protocol or study procedures",
"criterion": "compliance with protocol or study procedures",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* Pregnant or breast-feeding.",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "breast-feeding",
"criterion": "breastfeeding",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* The researcher believe that the Patient is not suitable to participate in the study.",
"criterions": [
{
"exact_snippets": "The researcher believe that the Patient is not suitable to participate in the study.",
"criterion": "suitability for study participation",
"requirements": [
{
"requirement_type": "judgment",
"expected_value": "not suitable"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}