A Study Comparing Etoposide/Cisplatin With Irinotecan/Cisplatin to Treat Extensive Disease Small Lung Cancer
NCT ID: NCT00349492
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
372 participants
INTERVENTIONAL
2006-06-30
2013-10-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EP
etoposide + cisplatin
IP
irinotecan+cisplatin
Interventions
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IP
irinotecan+cisplatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease
* Uncontrolled serious infection
* Enrollment in other study within 30 days
18 Years
ALL
No
Sponsors
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Clinical Research Center for Solid Tumor, Korea
OTHER
Responsible Party
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Hyeong-Seok Lim
Dae Seog Heo, professor
Principal Investigators
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Dae Seog Heo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Soonchunhyang University Bucheon Hospital
Bucheon-si, , South Korea
Yeungnam University Hospital
Daegu, , South Korea
Daegu Catholic University Hospital
Daegu, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Yonsei Cancer Center
Seoul, , South Korea
Seoul Veterans Hospital
Seoul, , South Korea
Kangnam St.Mary's Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Chung-Ang University Medical Center
Seoul, , South Korea
Seoul Municipal Boramae Hospital
Seoul, , South Korea
St.Vincent Hospital
Suwon, , South Korea
Countries
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Other Identifiers
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CRCST-L-0001
Identifier Type: -
Identifier Source: org_study_id