Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016211
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2001-05-06
Brief Title:
Radiation Therapy to Prevent Brain Metastases in Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Prophylactic Cranial Irradiation In Extensive Disease Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-09
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 Radiation therapy to the brain may be effective in preventing brain metastases It is not yet known if radiation therapy is effective following chemotherapy in preventing brain metastases
PURPOSE Randomized phase III trial to determine the effectiveness of radiation therapy in preventing brain metastases in patients who have received chemotherapy for extensive-stage small cell lung cancer
PURPOSE Randomized phase III trial to determine the effectiveness of radiation therapy in preventing brain metastases in patients who have received chemotherapy for extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the incidence of and time to symptomatic brain metastases in patients with previously treated extensive stage small cell lung cancer treated with prophylactic cranial irradiation vs no further therapy
Compare the quality of life and survival of these patients
Determine the toxicity of this regimen in these patients
Determine the health economics associated with this study
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and performance status Patients are randomized to 1 of 2 treatment arms
Arm I Within 5 weeks after completion of prior chemotherapy patients undergo prophylactic cranial irradiation once daily for 5-12 days
Arm II Patients receive no further therapy after completion of prior chemotherapy
Quality of life is assessed at baseline 6 weeks every 3 months for 1 year and then every 6 months thereafter
Patients are followed at 6 weeks every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 287 patients will be accrued for this study within 3 years
Compare the incidence of and time to symptomatic brain metastases in patients with previously treated extensive stage small cell lung cancer treated with prophylactic cranial irradiation vs no further therapy
Compare the quality of life and survival of these patients
Determine the toxicity of this regimen in these patients
Determine the health economics associated with this study
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and performance status Patients are randomized to 1 of 2 treatment arms
Arm I Within 5 weeks after completion of prior chemotherapy patients undergo prophylactic cranial irradiation once daily for 5-12 days
Arm II Patients receive no further therapy after completion of prior chemotherapy
Quality of life is assessed at baseline 6 weeks every 3 months for 1 year and then every 6 months thereafter
Patients are followed at 6 weeks every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 287 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| EORTC-LCG-08993 | None | None | None |
| EORTC-RA-22993 | None | None | None |