Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB NSCLC
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|ClinicalTrials.gov Identifier: NCT00030810|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 15, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Radiation: Hyperfractionated Drug: Taxotere/Cisplatin Procedure: conventional surgery||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial|
|Study Start Date :||September 2001|
|Primary Completion Date :||May 2006|
|Study Completion Date :||May 2006|
- Rate of event-free survival measured 1 year after registration
- Operability after chemotherapy
- Postoperative mortality 30 days after surgery
- Complete resection rate after surgery
- Response rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030810
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Study Chair:||Roger Stupp, MD||Centre Hospitalier Universitaire Vaudois|