Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014326
Status:
TERMINATED
Last Update Posted:
2012-07-16
First Post:
2001-04-10
Brief Title:
Involved-Field Radiation Therapy in Treating Patients With Previously Untreated Stage I or Stage II Low-Grade Non-Hodgkins Lymphoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Phase III Randomized Study On Low-Dose Total Body Irradiation And Involved Field Radiotherapy In Patients With Localized Stages I and II Low Grade Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 Giving radiation therapy in different ways may kill more tumor cells It is not yet known which regimen of radiation therapy is more effective for non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy to the involved area with or without total-body irradiation in treating patients who have low-grade stage I or stage II non-Hodgkins lymphoma that has not previously been treated
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy to the involved area with or without total-body irradiation in treating patients who have low-grade stage I or stage II non-Hodgkins lymphoma that has not previously been treated
Detailed Description:
OBJECTIVES
Determine if the addition of low-dose total body irradiation TBI to involved-field radiotherapy improves the disease-free survival of patients with previously untreated stage I or II low-grade non-Hodgkins lymphoma
Determine the response of patients treated with low-dose TBI
Compare the overall survival and quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center stage I vs II performance status 0-1 vs 2 lactate dehydrogenase elevation yes vs no histological subtype small lymphocytic lymphoma vs lymphoplasmacytoid lymphoma vs follicular lymphoma and for stage I patients presence of measurable mass yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo involved-field radiotherapy daily five days a week for 25-4 weeks
Arm II Patients undergo low-dose total body irradiation TBI daily 5 days a week on weeks 1 and 4 At 4 weeks after completion of TBI patients undergo involved-field radiotherapy as in arm I
Quality of life is assessed before treatment at 4 weeks after completion of involved-field radiotherapy every 6 months for 5 years and then annually thereafter
Patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 344 patients will be accrued for this study within 6 years
Determine if the addition of low-dose total body irradiation TBI to involved-field radiotherapy improves the disease-free survival of patients with previously untreated stage I or II low-grade non-Hodgkins lymphoma
Determine the response of patients treated with low-dose TBI
Compare the overall survival and quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center stage I vs II performance status 0-1 vs 2 lactate dehydrogenase elevation yes vs no histological subtype small lymphocytic lymphoma vs lymphoplasmacytoid lymphoma vs follicular lymphoma and for stage I patients presence of measurable mass yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo involved-field radiotherapy daily five days a week for 25-4 weeks
Arm II Patients undergo low-dose total body irradiation TBI daily 5 days a week on weeks 1 and 4 At 4 weeks after completion of TBI patients undergo involved-field radiotherapy as in arm I
Quality of life is assessed before treatment at 4 weeks after completion of involved-field radiotherapy every 6 months for 5 years and then annually thereafter
Patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 344 patients will be accrued for this study within 6 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-22997 | None | None | None |
| EORTC-20971 | None | None | None |