A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage
NCT00168896
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- cytological or histological proven SCLC Stage I or II at 1st diagnosis
- no prior chemotherapy
- measurable tumor disease
- karnofsky performance 70
- second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri)
- NYHA III
- chronic diarrhea, obstructive bowel syndrome
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Descriptive Information | ||||
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Brief Title ICMJE | A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage | |||
Official Title ICMJE | A Randomised Phase II/III Study to Compare the Combination of Carboplatin Plus Irinotecan Vs. the Combination of Carboplatin Plus Etoposide for SCLC in Extensive Disease Stage | |||
Brief Summary | Comparison of two combination chemotherapies in the treatment of patients with SLCL | |||
Detailed Description | Comparison of two combination chemotherapies in the treatment of patients with SLCL The combination chemotherapies for this study are Carboplatin plus Irinotecan versus Carboplatin plus Etoposide. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Small Cell Lung Cancer | |||
Intervention ICMJE | Drug: Carboplatin plus Irinotecan vs Carboplatin plus Etoposide | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* 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 | |||
Enrollment ICMJE | 286 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | December 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 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 | Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00168896 | |||
Other Study ID Numbers ICMJE | Haema CBF SCLC UK/AS 01 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Charite University, Berlin, Germany | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Charite University, Berlin, Germany | |||
Verification Date | September 2001 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |