Low-Dose Radiation Therapy in Treating Patients With Follicular or Marginal Zone Non-Hodgkin's Lymphoma (FoRT)
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|ClinicalTrials.gov Identifier: NCT00310167|
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : November 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Radiation: radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||614 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||January 2017|
Experimental: 4 Gy
4 Gy in 2 fractions
Radiation: radiation therapy
Active Comparator: 24 Gy
24 Gy in 12 fractions
Radiation: radiation therapy
- Local progression-free interval in irradiated field [ Time Frame: up to 5 years after randomisation ]Time form randomisation to tumour progression within the irradiated field
- Acute toxicity [ Time Frame: at 4 weeks after randomization ]
- Late toxicity [ Time Frame: from 12 weeks after randomisation up to 5 years ]
- Tumor response in irradiated area at 12 weeks after randomization [ Time Frame: at 12 weeks after randomization ]
- Overall survival [ Time Frame: up to 5 years after randomisation ]
- Health economic assessment [ Time Frame: up to 5 years after randomisation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310167
|Cancer Research UK and University College London Cancer Trials Centre|
|London, England, United Kingdom, W1T 4TJ|