Status:
COMPLETED
A Study Comparing Etoposide/Cisplatin With Irinotecan/Cisplatin to Treat Extensive Disease Small Lung Cancer
Lead Sponsor:
Clinical Research Center for Solid Tumor, Korea
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. Ar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2013
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT00349492
Start Date
June 1 2006
End Date
October 1 2013
Last Update
December 4 2013
Active Locations (14)
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1
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea, 420-767
2
Yeungnam University Hospital
Daegu, South Korea, 705-717
3
Daegu Catholic University Hospital
Daegu, South Korea, 705-718
4
Gyeongsang National University Hospital
Jinju, South Korea, 660-702