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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


Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Small Cell Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary Endpoint:

Principal Investigator

Ulrich Keilholz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charité Campus Benjamin Franklin University Clinic

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

Haema CBF SCLC UK/AS 01

NCT ID:

NCT00168896

Start Date:

October 2001

Completion Date:

December 2006

Related Keywords:

  • Small Cell Lung Cancer
  • SCLC
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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