Lymphoma
Conditions
Keywords
stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, Marginal zone lymphoma
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.
Interventions
RADIATIONradiation therapy
Sponsors
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local progression-free interval in irradiated field | up to 5 years after randomisation | Time form randomisation to tumour progression within the irradiated field |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response in irradiated area at 12 weeks after randomization | at 12 weeks after randomization |
| Overall survival | up to 5 years after randomisation |
| Health economic assessment | up to 5 years after randomisation |
| Acute toxicity | at 4 weeks after randomization |
| Late toxicity | from 12 weeks after randomisation up to 5 years |
Countries
United Kingdom
Outcome results
None listed