Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient (COMBAT)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by In-Jae, Oh, MD, Chonnam National University Hospital.
Recruitment status was: Recruiting
Chong Kun Dang Pharmaceutical
Information provided by (Responsible Party):
In-Jae, Oh, MD, Chonnam National University Hospital
First received: January 21, 2009
Last updated: January 9, 2012
Last verified: January 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 Overall response duration, Time to progression, Overall survival
Carcinoma, Small Cell
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
||A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2012 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||19 Years to 80 Years (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- ECOG Performance status 0~2(those with performance status 2 must have been stable with no deterioration over the previous 2 weeks)
- Histologically or cytologically confirmed small cell lung cancer Patient without chemotherapy and radiotherapy
- Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
- Life expectancy of at least 3 months
- Provision of written informed consent
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease
- Serum bilirubin greater than 3 times the upper limit of reference range(ULRR)
- Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT)greater than 2.5 times ULN if no demonstrable liver metastases (or > 5 times in presence of liver metastases)
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
- Pregnancy or breast-feeding women(women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
- Evidence of brain metastasis
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00826644
|Chonnam National University Hwasun Hospital
|Hwasun-gun, Jeonnam, Korea, Republic of |
|Contact: In-Jae Oh, M.D.,Ph.D. 82-61-379-7617 firstname.lastname@example.org |
Chonnam National University Hospital
Chong Kun Dang Pharmaceutical
||In-Jae Oh, M.D.,Ph.D.
||Chonnam National University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Oh IJ, Kim KS, Park CK, Kim YC, Lee KH, Jeong JH, Kim SY, Lee JE, Shin KC, Jang TW, Lee HK, Lee KY, Lee SY. Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial. BMC Cancer. 2016 Aug 26;16:690. doi: 10.1186/s12885-016-2741-z.
||In-Jae, Oh, MD, Assistant Professor, Chonnam National University Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 21, 2009
||January 9, 2012
Keywords provided by In-Jae, Oh, MD, Chonnam National University Hospital:
Small cell lung cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 25, 2017
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors