- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00812266
Topotecan and Cisplatin Versus Etoposide and Carboplatin in 1st Line Treatment of Patients With Small Cell Lung Cancer and Extensive Disease (SCLC-ED)
January 23, 2016 updated by: Seppo W. Langer, Danish Oncological Lung Cancer Group
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
281
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Copenhagen, Denmark
- Dept. Oncology, Rigshospitalet
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Topotecan + cisplatin
|
topotecan IV 2 mg/sqm d1-3 + cisplatin IV 50 mg/sqm d3 q3W
|
Active Comparator: B
Etoposide + carboplatin
|
Etoposide 120 mg/sqm IV d 1-3 + carboplatin AUC 5 d1 q3W
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
2 years survival
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rates
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Seppo W Langer, MD PhD, Dept. of Oncology, Rigshospitalet, Copenhagen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
December 19, 2008
First Submitted That Met QC Criteria
December 19, 2008
First Posted (Estimate)
December 22, 2008
Study Record Updates
Last Update Posted (Estimate)
January 26, 2016
Last Update Submitted That Met QC Criteria
January 23, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Carboplatin
- Etoposide
- Cisplatin
- Topotecan
Other Study ID Numbers
- DOLG7 (Other Identifier: Danish Oncological Lung Cancer Group Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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