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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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.

Conditions

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Lymphoma

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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4 Gy

4 Gy in 2 fractions

Group Type EXPERIMENTAL

radiation therapy

Intervention Type RADIATION

24 Gy

24 Gy in 12 fractions

Group Type ACTIVE_COMPARATOR

radiation therapy

Intervention Type RADIATION

Interventions

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radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cancer Research UK and University College London Cancer Trials Centre

London, England, United Kingdom

Site Status

Countries

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United Kingdom

References

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Hoskin P, Popova B, Schofield O, Brammer C, Robinson M, Brunt AM, Madhavan K, Illidge T, Gallop-Evans E, Syndikus I, Clifton-Hadley L, Kirkwood AA. 4 Gy versus 24 Gy radiotherapy for follicular and marginal zone lymphoma (FoRT): long-term follow-up of a multicentre, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2021 Mar;22(3):332-340. doi: 10.1016/S1470-2045(20)30686-0. Epub 2021 Feb 1.

Reference Type DERIVED

PMID: 33539729 (View on PubMed)

Hoskin PJ, Kirkwood AA, Popova B, Smith P, Robinson M, Gallop-Evans E, Coltart S, Illidge T, Madhavan K, Brammer C, Diez P, Jack A, Syndikus I. 4 Gy versus 24 Gy radiotherapy for patients with indolent lymphoma (FORT): a randomised phase 3 non-inferiority trial. Lancet Oncol. 2014 Apr;15(4):457-63. doi: 10.1016/S1470-2045(14)70036-1. Epub 2014 Feb 24.

Reference Type DERIVED

PMID: 24572077 (View on PubMed)