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OpenTrials
Completed

NCT Number: NCT00826644

Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient

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

* to assess Response Rate

Secondary endpoints

* to assess Overall response duration, Time to progression, Overall survival

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Belotecan

Drug

Belotecan : 0.5mg/㎡/day for Day 1 to 4, repeated every 3 weeks

Other names: Camtobell

etoposide

Drug

Etoposide 100mg/㎡/day for Day 1 to 3, repeated every 3 weeks

Cisplatin

Drug

Cisplatin 60mg/㎡/day for Day 1, repeated every 3 weeks

Primary outcomes

  1. 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 outcomes

  1. to assess the overall response duration

    Time frame: two years

  2. To assess the time to progression

    Time frame: two years

  3. to assess the overall survival

    Time frame: two years

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Collaborators

  • Chong Kun Dang Pharmaceutical

Registry information

Official study title

A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer

Acronym: COMBAT

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 22, 2009
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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