Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410683
Status:
UNKNOWN
Last Update Posted:
2020-11-20
First Post:
2006-12-11
Brief Title:
Radiation Therapy in Treating Patients With Non Small Cell Lung Cancer That Has Been Completely Removed by Surgery
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
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
Status Verified Date:
2020-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUNG ART
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20061202 | OTHER | None | None |
| PROTEGE-010601 | OTHER | None | None |
| 20671 | OTHER | None | None |
| IFCT - 0503 | OTHER | None | None |
| UK11NW0075 | OTHER | The Christie NHS Foundation Trust | None |