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

Phase 3

• Conditions: Non-small Cell Lung Cancer
• Interventions: Other: clinical observation; Procedure: adjuvant therapy; Radiation: 3-dimensional conformal radiation therapy

• Registration Number: NCT00410683
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief 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.

Study Timeline

• Study First Submitted: 2006-12-11
• Study First Submitted QC: 2006-12-11
• Study First Posted: 2006-12-13
• Study Start: 2007-02
• Primary Completion: 2018-07
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-20
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy	adjuvant therapy	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.
No radiotherapy	clinical observation	Patients do not undergo adjuvant thoracic radiotherapy. After completion of study therapy, patients are followed periodically for up to 10 years.
Radiotherapy	clinical observation	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.
Radiotherapy	3-dimensional conformal radiation therapy	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.
No radiotherapy	adjuvant therapy	Patients do not undergo adjuvant thoracic radiotherapy. After completion of study therapy, patients are followed periodically for up to 10 years.

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)	assessed up every 3 and 6 months after randomization, every 6 months for the fist three years and yearly afterward

Secondary Outcome Measures

Name	Time	Method
Prognostic and predictive factors of treatment effect on DFS and OS	assessed up at the end of the study
Cost per recurrence-free year of life	Assessed up at the end of the study
Acute and late toxicity (with identification of predictive factors of toxicity)	assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event
Patterns of failure	assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event
Overall survival (OS)	assessed up In case of death whatever the cause
Local control	assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event
Second cancers	Assessed up in case of event

Trial Locations

Locations (1)

Institut Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France