A Study Comparing Etoposide/Cisplatin With Irinotecan/Cisplatin to Treat Extensive Disease Small Lung Cancer
Small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Small Cell Lung Cancer, Extensive Disease, Chemotherapy, Randomisation
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically diagnosed small cell lung cancer Extensive disease (distant metastasis, contralateral hilar lymph node involvement, or cytologically confirmed malignant pleural effusion) If patients have brain metastasis with neurological symptom, they should be stabilized neurologically with prior radiotherapy or surgery for the brain metastasis (no neurologic symptom in progress and without further steroid treatment) No prior chemotherapy, immunotherapy, surgery or radiotherapy for small cell lung cancer (Local radiotherapy for brain or bone metastasis with symptom is permitted, in which case patients can be enrolled in this study when they have recovered from toxicity of radiotherapy) One or more measurable disease by RECIST criteria at least 18 years of age Performance status of 0, 1 and 2 on the Eastern Cooperative Oncology Group (ECOG) criteria Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL) function Informed consent from patient which conforms to Institutional Review Board Exclusion Criteria: History of cured basal cell carcinoma or cured uterine cervical malignancy except for carcinoma in situ within 5 years Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease Uncontrolled serious infection Enrollment in other study within 30 days
Sites / Locations
- Soonchunhyang University Bucheon Hospital
- Yeungnam University Hospital
- Daegu Catholic University Hospital
- Gyeongsang National University Hospital
- Seoul National University Bundang Hospital
- Seoul National University Hospital
- Kangbuk Samsung Hospital
- Yonsei Cancer Center
- Seoul Veterans Hospital
- Kangnam St.Mary's Hospital
- Asan Medical Center
- Chung-Ang University Medical Center
- Seoul Municipal Boramae Hospital
- St.Vincent Hospital
Arms of the Study
Arm 1
Active Comparator
EP
etoposide + cisplatin