Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient (COMBAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00826644|
Recruitment Status : Unknown
Verified January 2012 by In-Jae, Oh, MD, Chonnam National University Hospital.
Recruitment status was: Recruiting
First Posted : January 22, 2009
Last Update Posted : January 10, 2012
Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer.
- to assess Response Rate
- to assess Overall response duration, Time to progression, Overall survival
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Small Cell||Drug: Belotecan/Cisplatin Drug: Etoposide/Cisplatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||December 2012|
Belotecan : 0.5mg/㎡/day for Day 1 to 4, Cisplatin : 60mg/㎡/day for Day 1.
|Active Comparator: Etoposide||
Etoposide : 100mg/㎡/day for Day 1 to 3, Cisplatin : 60mg/㎡/day for Day 1. Repeat next cycle at Day 22.
- To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer [ Time Frame: two years ]
- to assess the overall response duration [ Time Frame: two years ]
- To assess the time to progression [ Time Frame: two years ]
- to assess the overall survival [ Time Frame: two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826644
|Contact: In-Jae Oh, M.D.,Ph.D.||firstname.lastname@example.org|
|Contact: Kyu-Sik Kim, M.D.,Ph.D.||email@example.com|
|Korea, Republic of|
|Chonnam National University Hwasun Hospital||Recruiting|
|Hwasun-gun, Jeonnam, Korea, Republic of|
|Contact: In-Jae Oh, M.D.,Ph.D. 82-61-379-7617 firstname.lastname@example.org|
|Principal Investigator:||In-Jae Oh, M.D.,Ph.D.||Chonnam National University Hospital|