A Study Comparing Etoposide/Cisplatin With Irinotecan/Cisplatin to Treat Extensive Disease Small Lung Cancer
- Conditions
- Small Cell Lung Cancer
- Interventions
- Drug: IP
- Registration Number
- NCT00349492
- Lead Sponsor
- Clinical Research Center for Solid Tumor, Korea
- Brief Summary
This study is a randomized, multi-center clinical trial. Patients are stratified according to performance status (ECOG 0, 1 vs 2) and institution. Patients are randomized to 1 of 2 treatment arms.
Arm A: Patients receive etoposide IV on days 1, 2, 3 and cisplatin IV on day 1. Courses repeat every 3 weeks Arm B: Patients receive irinotecan IV on days 1, 8 and cisplatin IV on day 1. Coursed repeated every 3 weeks
Treatment in both arms continues for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1.5 years
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 372
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EP IP etoposide + cisplatin
- Primary Outcome Measures
Name Time Method Overall survival month
- Secondary Outcome Measures
Name Time Method Objective response rate percent Progression free survival month Safety profile percent
Trial Locations
- Locations (14)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
St.Vincent Hospital
🇰🇷Suwon, Korea, Republic of
Chung-Ang University Medical Center
🇰🇷Seoul, Korea, Republic of
Yeungnam University Hospital
🇰🇷Daegu, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-Si, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
Daegu Catholic University Hospital
🇰🇷Daegu, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Bucheon-si, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei Cancer Center
🇰🇷Seoul, Korea, Republic of
Kangnam St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Seoul Municipal Boramae Hospital
🇰🇷Seoul, Korea, Republic of
Seoul Veterans Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of