Low-Dose Radiation Therapy in Treating Patients With Follicular or Marginal Zone Non-Hodgkin's Lymphoma (FoRT)
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-Hodgkin's 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-Hodgkin's lymphoma.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma|
- Local progression-free interval in irradiated field [ Time Frame: up to 5 years after randomisation ] [ Designated as safety issue: No ]Time form randomisation to tumour progression within the irradiated field
- Acute toxicity [ Time Frame: at 4 weeks after randomization ] [ Designated as safety issue: Yes ]
- Late toxicity [ Time Frame: from 12 weeks after randomisation up to 5 years ] [ Designated as safety issue: Yes ]
- Tumor response in irradiated area at 12 weeks after randomization [ Time Frame: at 12 weeks after randomization ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: up to 5 years after randomisation ] [ Designated as safety issue: No ]
- Health economic assessment [ Time Frame: up to 5 years after randomisation ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: 4 Gy
4 Gy in 2 fractions
|Radiation: radiation therapy|
Active Comparator: 24 Gy
24 Gy in 12 fractions
|Radiation: radiation therapy|
- Compare the local progression-free interval in patients with follicular non-Hodgkin's lymphoma (NHL) treated with 2 different regimens of low-dose radiotherapy.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310167
|Cancer Research UK and University College London Cancer Trials Centre|
|London, England, United Kingdom, W1T 4TJ|