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Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
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| Phase III | Treatment | Active | 19 to 80 | CSCLC-0810
NCT00826644 |
Trial Description
Summary 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. Primary endpoints Secondary endpoints - to assess Overall response duration, Time to progression, Overall survival
Eligibility Criteria Inclusion Criteria: - 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
Exclusion Criteria: - 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
Trial Contact Information
Trial Lead Organizations/Sponsors Chonnam National University Hwasun Hospital Chong Kun Dang
| Kyu-Sik Kim, M.D.,Ph.D. | | Principal Investigator |
Trial Sites
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| Republic of Korea |
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Hwasun-gun, Jeonnam |
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| | | | | | | | Chonnam National University Hwasun Hospital |
| | | Kyu-Sik Kim, M.D.,Ph.D. |
Ph: 82-61-379-7615 |
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Email:
cyberkks@chonnam.ac.kr |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00826644
Information obtained from ClinicalTrials.gov on April 17, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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