Back to resultsTopotecan and Cisplatin Versus Etoposide and Carboplatin in 1st Line Treatment of Patients With Small Cell Lung Cancer and Extensive Disease (SCLC-ED)
Primary Purpose
Extensive Disease, First-Line, Small Cell Lung Cancer
Status
Terminated
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
topotecan + cisplatin
Etoposide + carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Extensive Disease focused on measuring SCLC, Extensive disease, topotecan
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed SCLC
- Extensive stage
- No prior chemotherapy
- WHO PS 0-3
- Adequate organ function (liver, kidney)
- Adequate hematology (bone marrow)
- Informed consent
Exclusion Criteria:
- PS 4
- Inadequate organ function
- Uncontrolled infection
- Concomitant major medical contraindications
Sites / Locations
- Dept. Oncology, Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Topotecan + cisplatin
Etoposide + carboplatin
Outcomes
Primary Outcome Measures
2 years survival
Secondary Outcome Measures
Response rates
Full Information
NCT ID
NCT00812266
First Posted
December 19, 2008
Last Updated
January 23, 2016
Sponsor
Danish Oncological Lung Cancer Group
1. Study Identification
Unique Protocol Identification Number
NCT00812266
Brief Title
Topotecan and Cisplatin Versus Etoposide and Carboplatin in 1st Line Treatment of Patients With Small Cell Lung Cancer and Extensive Disease (SCLC-ED)
Official Title
Randomized Phase III Trial of Topotecan and Cisplatin Versus Etoposide and Carboplatin in the Treatment of Patients With Previously Untreated Small Cell Lung Cancer and Extensive Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Oncological Lung Cancer Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomised trial comparing standard chemotherapy with carboplatin and etoposide with a combination of topotecan and cisplatin in patients with inoperable lung cancer of small cell type.
Detailed Description
Fase III, multicenter randomised trial comparing up to six cycles of carboplatin and etoposide with up to six cycles of topotecan and cisplatin in patients with extensive stage small cell lung cancer and PS 0-3
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive Disease, First-Line, Small Cell Lung Cancer
Keywords
SCLC, Extensive disease, topotecan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
281 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Topotecan + cisplatin
Arm Title
B
Arm Type
Active Comparator
Arm Description
Etoposide + carboplatin
Intervention Type
Drug
Intervention Name(s)
topotecan + cisplatin
Intervention Description
topotecan IV 2 mg/sqm d1-3 + cisplatin IV 50 mg/sqm d3 q3W
Intervention Type
Drug
Intervention Name(s)
Etoposide + carboplatin
Intervention Description
Etoposide 120 mg/sqm IV d 1-3 + carboplatin AUC 5 d1 q3W
Primary Outcome Measure Information:
Title
2 years survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Response rates
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed SCLC
Extensive stage
No prior chemotherapy
WHO PS 0-3
Adequate organ function (liver, kidney)
Adequate hematology (bone marrow)
Informed consent
Exclusion Criteria:
PS 4
Inadequate organ function
Uncontrolled infection
Concomitant major medical contraindications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seppo W Langer, MD PhD
Organizational Affiliation
Dept. of Oncology, Rigshospitalet, Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. Oncology, Rigshospitalet
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Topotecan and Cisplatin Versus Etoposide and Carboplatin in 1st Line Treatment of Patients With Small Cell Lung Cancer and Extensive Disease (SCLC-ED)
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