A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage
NCT00168896
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Adult Trials: 18+ Years
- 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 | ||||
|---|---|---|---|---|
| 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:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| Investigators ICMJE |
| |||
| 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 | ||||