NCT00003317

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Stage IIIA Non-small Cell Lung Cancer

A Phase III Study of Surgical Resection and Chemotherapy (Paclitaxel and Carboplatin) With or Without Adjuvant Radiotherapy for Resected Stage IIIA Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · 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. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy for stage IIIA non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have stage IIIA non-small cell lung cancer that has been surgically removed.

Detailed description

OBJECTIVES: I. Compare the overall survival of surgically resected patients with limited stage IIIA non-small cell lung cancer who are treated by postoperative chemotherapy with or without adjuvant radiotherapy. II. Compare failure free survival of these patients. III. Describe the patterns of local and distant recurrence in these patients. IV. Determine the toxicities associated with chemotherapy with or without adjuvant radiotherapy in these patients. OUTLINE: This is a randomized, multicenter study. Four to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients are randomized into one of two treatment arms.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	paclitaxel
RADIATION	radiation therapy
PROCEDURE	surgery

Timeline

• Start date: 1998-05-01
• Primary completion: 2005-06-01
• Completion: 2005-08-01
• First posted: 2004-06-24
• Last updated: 2016-07-13

Locations

16 sites across 1 country: United States