Combination Chemotherapy in Treating Patients Who Have Extensive-Stage Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00003696
- Lead Sponsor
- Commissie Voor Klinisch Toegepast Onderzoek
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective for extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with extensive-stage small cell lung cancer.
- Detailed Description
OBJECTIVES:
* Compare the effect of cyclophosphamide, doxorubicin, and etoposide with carboplatin and paclitaxel on progression free survival in patients with extensive stage small cell lung cancer.
* Compare the overall survival, response rate, duration of response, and toxic effects of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to institute and performance status (0-1 vs 2-3).
Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, and etoposide IV on days 1-3 every 3 weeks.
* Arm II: Patients receive carboplatin IV followed by paclitaxel IV over 3 hours on day 1 every 3 weeks.
Patients with stable or responding disease are treated for up to 5 courses.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 250 patients (125 per treatment arm) will be accrued within 24 months for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Overall survival Response rate Duration of response Toxicity
Trial Locations
- Locations (1)
Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Netherlands