A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage

Phase 2

• Conditions: Small Cell Lung Cancer

• Registration Number: NCT00168896
• Lead Sponsor: Charite University, Berlin, Germany

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 Timeline

• Status Verified: 2001-09
• Study Start: 2001-10
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Last Update Submitted: 2006-02-13
• Last Update Posted: 2006-02-14
• Study Completion: 2006-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

• cytological or histological proven SCLC Stage I or II at 1st diagnosis
• no prior chemotherapy
• measurable tumor disease
• karnofsky performance 70

Exclusion Criteria

• second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri)
• NYHA III
• chronic diarrhea, obstructive bowel syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Endpoint:
Documentation of the remission rate ( Phase II)
Determination of progress free time (Phase III)

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint:
Documentation of progress free time (Phase II)
Documentation of objective remission rate ( Phase III)
Documentation of 1-year survival rate
Documentation of safety of the drug combination

Trial Locations

Locations (1)

Hematology & Oncology Charité CBF Berlin, Germany; 🇩🇪 Berlin, Germany