A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Lymphoma
- Sponsor
- University College, London
- Enrollment
- 614
- Locations
- 1
- Primary Endpoint
- Local progression-free interval in irradiated field
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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-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.
Detailed Description
OBJECTIVES: Primary * Compare the local progression-free interval in patients with follicular non-Hodgkin's 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Health economic assessment(up to 5 years after randomisation)
- Overall survival(up to 5 years after randomisation)
- Late toxicity(from 12 weeks after randomisation up to 5 years)
- Tumor response in irradiated area at 12 weeks after randomization(at 12 weeks after randomization)
- Acute toxicity(at 4 weeks after randomization)