A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma
- 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
- 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,
In both arms, treatment continues in the absence of disease progression or unacceptable
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Local progression-free interval in irradiated field
Time form randomisation to tumour progression within the irradiated field
up to 5 years after randomisation
United Kingdom: NHS Health Research Authority