A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University College, London
- Enrollment
- 614
- Locations
- 1
- Primary Endpoint
- Local progression-free interval in irradiated field
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed follicular or mmarginal zone non-Hodgkin's lymphoma (NHL)
- •Any stage
- •Radiotherapy is indicated for curative treatment of stage IA or IIA disease OR palliation due to tumor bulk or anatomical position
- •PATIENT CHARACTERISTICS:
- •Life expectancy > 3 months
- •PRIOR CONCURRENT THERAPY:
- •More than 4 weeks since prior chemotherapy
Exclusion Criteria
- Not provided
Arms & Interventions
4 Gy
4 Gy in 2 fractions
Intervention: radiation therapy (Radiation)
24 Gy
24 Gy in 12 fractions
Intervention: radiation therapy (Radiation)
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)