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

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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
Sponsor:
Collaborator:
Chong Kun Dang Pharmaceutical
Information provided by (Responsible Party):
In-Jae, Oh, MD, Chonnam National University Hospital

Tracking Information
First Submitted Date  ICMJE January 21, 2009
First Posted Date  ICMJE January 22, 2009
Last Update Posted Date January 10, 2012
Study Start Date  ICMJE January 2009
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00826644 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient
Official Title  ICMJE A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer
Brief 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

  • to assess Response Rate

Secondary endpoints

  • to assess Overall response duration, Time to progression, Overall survival
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Small Cell
Intervention  ICMJE
  • Drug: Belotecan/Cisplatin
    Belotecan : 0.5mg/㎡/day for Day 1 to 4, Cisplatin : 60mg/㎡/day for Day 1.
  • Drug: Etoposide/Cisplatin
    Etoposide : 100mg/㎡/day for Day 1 to 3, Cisplatin : 60mg/㎡/day for Day 1. Repeat next cycle at Day 22.
Study Arms  ICMJE
  • Experimental: Belotecan
    Intervention: Drug: Belotecan/Cisplatin
  • Active Comparator: Etoposide
    Intervention: Drug: Etoposide/Cisplatin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 21, 2009)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00826644
Other Study ID Numbers  ICMJE CSCLC-0810
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party In-Jae, Oh, MD, Chonnam National University Hospital
Study Sponsor  ICMJE Chonnam National University Hospital
Collaborators  ICMJE Chong Kun Dang Pharmaceutical
Investigators  ICMJE
Principal Investigator: In-Jae Oh, M.D.,Ph.D. Chonnam National University Hospital
PRS Account Chonnam National University Hospital
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP