This trial is active, not recruiting.

Condition lymphoma
Treatment radiation therapy
Phase phase 3
Sponsor University College, London
Start date October 2005
End date July 2013
Trial size 614 participants
Trial identifier NCT00310167, CRUK-BRD/05/84, CRUK-FORT, EU-20601, EUDRACT-2005-002416-19, ISRCTN65687030, UCL/05/84


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
4 Gy in 2 fractions
radiation therapy
(Active Comparator)
24 Gy in 12 fractions
radiation therapy

Primary Outcomes

Local progression-free interval in irradiated field
time frame: up to 5 years after randomisation

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University College, London.