NCT00310167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
614

participants targeted

Target at P75+ for phase_3 lymphoma

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_3 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

7.8 years

First QC Date

March 29, 2006

Last Update Submit

November 16, 2017

Conditions

Lymphoma

Keywords

stage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomacontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomaMarginal zone lymphoma

Outcome Measures

Primary Outcomes (1)

  • Local progression-free interval in irradiated field

    Time form randomisation to tumour progression within the irradiated field

    up to 5 years after randomisation

Secondary Outcomes (5)

  • Acute toxicity

    at 4 weeks after randomization

  • Late toxicity

    from 12 weeks after randomisation up to 5 years

  • 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

Study Arms (2)

4 Gy

EXPERIMENTAL

4 Gy in 2 fractions

Radiation: radiation therapy

24 Gy

ACTIVE COMPARATOR

24 Gy in 12 fractions

Radiation: radiation therapy

Interventions

radiation therapyRADIATION
24 Gy4 Gy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cancer Research UK and University College London Cancer Trials Centre

London, England, W1T 4TJ, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 33539729DERIVED

  • 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.

    PMID: 24572077DERIVED

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, B-Cell, Marginal Zone

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinLymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2006

First Posted

April 3, 2006

Study Start

October 1, 2005

Primary Completion

July 1, 2013

Study Completion

January 1, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

GB(1)