NCT00030810

Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB NSCLC

Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
RADIATION	Hyperfractionated	Hyperfractionated radiotherapy
DRUG	Taxotere/Cisplatin	Taxotere/Cisplatin
PROCEDURE	conventional surgery	conventional surgery

Timeline

• Start date: 2001-09-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2003-01-27
• Last updated: 2019-05-15

Locations

1 site across 1 country: Switzerland