Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048997
Status:
COMPLETED
Last Update Posted:
2018-06-08
First Post:
2002-11-12
Brief Title:
Radiation Therapy in Preventing Central Nervous System CNS Metastases in Patients With Non-Small Cell Lung Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Comparison Of Prophylactic Cranial Irradiation PCI Versus Observation In Patients With Locally Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
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:
None
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells It is not yet known if giving radiation therapy to the head is effective in preventing CNS metastases in patients who have stage III non-small cell lung cancer
PURPOSE This randomized phase III trial is studying how well radiation therapy to the head works in preventing CNS metastases in patients who have been previously treated for stage III non-small cell lung cancer
PURPOSE This randomized phase III trial is studying how well radiation therapy to the head works in preventing CNS metastases in patients who have been previously treated for stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine whether prophylactic cranial irradiation improves survival after effective locoregionalsystemic therapy in patients with stage IIIA or IIIB non-small cell lung cancer
Determine the neuropsychologic impact of this therapy in these patients
Assess quality of life of patients receiving this therapy
Determine the impact of this therapy on the incidence of CNS metastases in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage IIIA vs IIIB histology non-squamous cell vs squamous cell and prior surgery yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo prophylactic cranial irradiation 5 days a week for 3 weeks
Arm II Patients undergo observation
Patients are followed 3 months during the first year every 6 months for 2-3 years and then annually thereafter Quality of life is assessed at baseline and at months 6 12 24 36 and 48
PROJECTED ACCRUAL A total of 1058 patients 529 per treatment arm will be accrued for this study within 36 months
Determine whether prophylactic cranial irradiation improves survival after effective locoregionalsystemic therapy in patients with stage IIIA or IIIB non-small cell lung cancer
Determine the neuropsychologic impact of this therapy in these patients
Assess quality of life of patients receiving this therapy
Determine the impact of this therapy on the incidence of CNS metastases in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage IIIA vs IIIB histology non-squamous cell vs squamous cell and prior surgery yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo prophylactic cranial irradiation 5 days a week for 3 weeks
Arm II Patients undergo observation
Patients are followed 3 months during the first year every 6 months for 2-3 years and then annually thereafter Quality of life is assessed at baseline and at months 6 12 24 36 and 48
PROJECTED ACCRUAL A total of 1058 patients 529 per treatment arm will be accrued for this study within 36 months
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 |
|---|---|---|---|
| ECOG-RTOG-0214 | None | None | None |
| CDR0000257200 | None | None | None |