Low-Dose Radiation Therapy in Treating Patients With Follicular or Marginal Zone Non-Hodgkin's Lymphoma (FoRT)

University College London (UCL)

Status and phase: Completed; Phase 3

Conditions: Lymphoma

Treatments: Radiation: radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00310167

ISRCTN65687030

2005-002416-19 (EudraCT Number)

UCL/05/84

CRUK-FORT

CRUK-BRD/05/84

EU-20601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 614 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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614 participants in 2 patient groups

4 Gy

Experimental group

Description:

4 Gy in 2 fractions

Treatment:

Radiation: radiation therapy

24 Gy

Active Comparator group

Description:

24 Gy in 12 fractions

Treatment:

Radiation: radiation therapy