Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310167
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2006-03-29
Brief Title:
Low-Dose Radiation Therapy in Treating Patients With Follicular or Marginal Zone Non-Hodgkins Lymphoma
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma
Status:
COMPLETED
Status Verified Date:
2017-11
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:
FoRT
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to kill cancer cells It is not yet known which regimen of low-dose radiation therapy is more effective in treating follicular non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying two different regimens of low-dose radiation therapy 24Gy versus 4Gy to compare how well they work in treating patients with follicular or marginal zone non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying two different regimens of low-dose radiation therapy 24Gy versus 4Gy to compare how well they work in treating patients with follicular or marginal zone non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Compare the local progression-free interval in patients with follicular non-Hodgkins lymphoma NHL treated with 2 different regimens of low-dose radiotherapy
Secondary
Compare acute toxicity at 4 weeks in patients treated with these regimens
Compare late toxicity in patients treated with these regimens
Compare tumor response at 12 weeks in patients treated with these regimens
Compare overall survival in patients treated with these regimens
Assess the health economics of these regimens in these patients
OUTLINE This is a multicenter randomized study Patients are randomized to one of two treatment arms
Arm I 4Gy Patients undergo low-dose radiotherapy once daily on days 1 and 2
Arm II 24Gy Patients undergo low-dose radiotherapy once daily on days 1-5 8-12 15 and 16
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed up for 5 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 650 patients will be accrued for this study
Primary
Compare the local progression-free interval in patients with follicular non-Hodgkins lymphoma NHL treated with 2 different regimens of low-dose radiotherapy
Secondary
Compare acute toxicity at 4 weeks in patients treated with these regimens
Compare late toxicity in patients treated with these regimens
Compare tumor response at 12 weeks in patients treated with these regimens
Compare overall survival in patients treated with these regimens
Assess the health economics of these regimens in these patients
OUTLINE This is a multicenter randomized study Patients are randomized to one of two treatment arms
Arm I 4Gy Patients undergo low-dose radiotherapy once daily on days 1 and 2
Arm II 24Gy Patients undergo low-dose radiotherapy once daily on days 1-5 8-12 15 and 16
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed up for 5 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 650 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 |
|---|---|---|---|
| CRUK-FORT | None | None | None |
| CRUK-BRD0584 | None | None | None |
| 2005-002416-19 | EUDRACT_NUMBER | None | None |
| ISRCTN65687030 | None | None | None |
| EU-20601 | EudraCT Number | None | None |