NCT00410683

Radiation Therapy in Treating Patients With Non Small Cell Lung Cancer That Has Been Completely Removed by Surgery

Phase III Study Comparing Post-Operative Conformal Radiotherapy to No Post-Operative Radiotherapy in Patients With Completely Resected Non-Small Cell Lung Cancer and Mediastinal N2 Involvement [Lung ART]

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving radiation therapy after surgery is more effective than no radiation therapy in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no radiation therapy in treating patients with non-small cell lung cancer that has been completely removed by surgery.

Detailed description

OBJECTIVES: Primary * Compare the disease-free survival of patients with completely resected non-small cell lung cancer treated with conformal thoracic radiotherapy vs no radiotherapy. Secondary * Determine the toxicity, in particular cardiac and pulmonary toxicity, of these regimens in these patients. * Compare the local control in patients treated with these regimens. * Determine patterns of recurrence in patients treated with these regimens. * Determine the overall survival of patients treated with these regimens. * Assess second cancers in patients treated with these regimens. * Assess prognostic factors and predictive factors of treatment effect on disease-free survival and overall survival of patients treated with these regimens. * Determine the cost per recurrence-free year of life. OUTLINE: This is a multicenter, randomized study. Patients are stratified according to participating center, prior chemotherapy (neoadjuvant alone vs adjuvant vs none), number of lymph stations involved (0 vs 1 vs ≥ 2), histology (squamous cell vs other), and use of pretreatment positron emission tomography scans (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Beginning within 4-8 weeks after surgery or 2-6 weeks after chemotherapy, patients undergo adjuvant thoracic conformal radiotherapy once daily, 5 days per week, for 6 weeks. * Arm II: Patients do not undergo adjuvant thoracic radiotherapy. After completion of study therapy, patients are followed periodically for up to10 years. PROJECTED ACCRUAL: A total of 700 patients will be accrued for this study.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	clinical observation
PROCEDURE	adjuvant therapy
RADIATION	3-dimensional conformal radiation therapy

Timeline

• Start date: 2007-02-01
• Primary completion: 2018-07-01
• Completion: 2022-02-01
• First posted: 2006-12-13
• Last updated: 2020-11-20

Locations

1 site across 1 country: France