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

Primary Purpose

Carcinoma, Small Cell

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Belotecan
Etoposide
Cisplatin
Sponsored by
Chonnam National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Small Cell focused on measuring Small cell lung cancer, Camptothecin, Response rate

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chonnam National University Hwasun Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Belotecan plus Cisplatin

Etoposide plus Cisplatin

Arm Description

Outcomes

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

Secondary Outcome Measures

to assess the overall response duration
To assess the time to progression
to assess the overall survival

Full Information

First Posted
January 21, 2009
Last Updated
August 2, 2021
Sponsor
Chonnam National University Hospital
Collaborators
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00826644
Brief Title
Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient
Acronym
COMBAT
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 Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 2009 (Actual)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital
Collaborators
Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Small Cell
Keywords
Small cell lung cancer, Camptothecin, Response rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Belotecan plus Cisplatin
Arm Type
Experimental
Arm Title
Etoposide plus Cisplatin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Belotecan
Other Intervention Name(s)
Camtobell
Intervention Description
Belotecan : 0.5mg/㎡/day for Day 1 to 4, repeated every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Etoposide 100mg/㎡/day for Day 1 to 3, repeated every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 60mg/㎡/day for Day 1, repeated every 3 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
to assess the overall response duration
Time Frame
two years
Title
To assess the time to progression
Time Frame
two years
Title
to assess the overall survival
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Jae Oh, M.D.,Ph.D.
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
ZIP/Postal Code
58128
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27566413
Citation
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(1):690. doi: 10.1186/s12885-016-2741-z.
Results Reference
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Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient

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