NCT00006378

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

Phase II Randomized Study of Taxol (PACLITAXEL), Paraplatin (Carboplatin), and Radiation Therapy for Locally Advanced Inoperable Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 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 may kill more tumor cells PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens of combining paclitaxel and carboplatin plus radiation therapy in treating patients who have stage III non-small cell lung cancer that cannot be removed during surgery.

Detailed description

OBJECTIVES: I. Compare survival of patients with stage IIIA or IIIB unresectable non-small cell lung cancer treated with one of three different combined modality regimens of paclitaxel, carboplatin, and radiotherapy. II. Compare the safety and toxicity of these treatment regimens in these patients. III. Compare the relapse free survival rate in these patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 every 3 weeks for 2 courses, followed by radiotherapy 5 times a week for 7 weeks beginning on day 42. Arm II: Patients receive paclitaxel and carboplatin as in arm I followed by radiotherapy 5 times a week, paclitaxel IV over 1 hour, and carboplatin IV over 30 minutes weekly for 7 weeks beginning on day 42. Arm III: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly and radiotherapy 5 times a week for 7 weeks beginning on day 1, followed by paclitaxel IV over 3 hours and carboplatin IV over 30 minutes every 3 weeks for 2 courses beginning 3 weeks after concurrent chemotherapy and radiotherapy. Patients are followed every 3 months for 2 years, every 4 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 264 patients (88 per treatment arm) will be accrued for this study within 20 months.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	paclitaxel
RADIATION	radiation therapy

Timeline

• Start date: 1999-12-01
• Primary completion: 2003-04-01
• Completion: 2003-04-01
• First posted: 2004-06-09
• Last updated: 2014-01-09

Locations

3 sites across 1 country: United States