Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057746
Status:
COMPLETED
Last Update Posted:
2016-05-25
First Post:
2003-04-07
Brief Title:
Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-04
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 which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer while taking into account chronic neurotoxicity from radiation therapy
PURPOSE This randomized phase II trial compares the incidence of chronic neurotoxicity between three different brain irradiation regimens The corresponding phase III component addressing the prevention of brain metastases was run by EORTC and reported separately NCT00005062
PURPOSE This randomized phase II trial compares the incidence of chronic neurotoxicity between three different brain irradiation regimens The corresponding phase III component addressing the prevention of brain metastases was run by EORTC and reported separately NCT00005062
Detailed Description:
OBJECTIVES
Compare the incidence of chronic neurotoxicity in patients treated with these regimens
Compare quality of life of patients treated with these regimens phase III closed to accrual as of 123105
OUTLINE This is a randomized multicenter study Patients are stratified according to age 60 and under vs over 60 and time since induction therapy 90 days or less vs 91-180 days vs 181-240 days Patients are randomized to 1 of 3 treatment arms
Arm I Patients undergo prophylactic cranial irradiation PCI once daily 5 days a week Treatment continues for 2 weeks in the absence of unacceptable toxicity
Arm II Patients undergo PCI once daily 5 days a week Treatment continues for 26 weeks in the absence of unacceptable toxicity
Arm III Patients undergo PCI twice daily 5 days a week Treatment continues for 34 weeks in the absence of unacceptable toxicity
Quality of life is assessed at baseline every 6 months for 1 year and then annually for 3 years
Patients are followed every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 264 patients will be accrued for this study within 35 years
Compare the incidence of chronic neurotoxicity in patients treated with these regimens
Compare quality of life of patients treated with these regimens phase III closed to accrual as of 123105
OUTLINE This is a randomized multicenter study Patients are stratified according to age 60 and under vs over 60 and time since induction therapy 90 days or less vs 91-180 days vs 181-240 days Patients are randomized to 1 of 3 treatment arms
Arm I Patients undergo prophylactic cranial irradiation PCI once daily 5 days a week Treatment continues for 2 weeks in the absence of unacceptable toxicity
Arm II Patients undergo PCI once daily 5 days a week Treatment continues for 26 weeks in the absence of unacceptable toxicity
Arm III Patients undergo PCI twice daily 5 days a week Treatment continues for 34 weeks in the absence of unacceptable toxicity
Quality of life is assessed at baseline every 6 months for 1 year and then annually for 3 years
Patients are followed every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 264 patients will be accrued for this study within 35 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 |
|---|---|---|---|
| CDR0000258668 | None | None | None |