Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB NSCLC
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.
Procedure: conventional surgery
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial|
- Rate of event-free survival measured 1 year after registration [ Designated as safety issue: No ]
- Operability after chemotherapy [ Designated as safety issue: No ]
- Postoperative mortality 30 days after surgery [ Designated as safety issue: No ]
- Complete resection rate after surgery [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Response rate [ Designated as safety issue: No ]
|Study Start Date:||September 2001|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
- Determine the feasibility and efficacy of sequential neoadjuvant docetaxel, cisplatin, and radiotherapy followed by surgery in patients with operable stage IIIB non-small cell lung cancer.
- Determine the rate of event-free survival at 1 year in patients treated with this regimen.
- Determine the operability and complete resection rate in patients treated with this regimen.
- Determine the postoperative 30-day mortality in patients treated with this regimen.
- Determine the response rate, failure pattern, and overall survival in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity.
Beginning 3 weeks after the last chemotherapy dose, patients without progressive disease receive radiotherapy 1-2 times daily on days 1-5, 8-12, and 15-19.
Patients undergo surgery within 3-4 weeks after completion of radiotherapy.
Patients are followed at 1 month and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-46 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030810
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Study Chair:||Roger Stupp, MD||Centre Hospitalier Universitaire Vaudois|