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

• ClinicalTrials.gov Identifier: NCT00310167
• Recruitment Status: Completed
• First Posted: April 3, 2006
• Last Update Posted: November 17, 2017
• Sponsor: University College, London
• Information provided by (Responsible Party): University College, London

Tracking Information

• First Submitted Date: March 29, 2006
• First Posted Date: April 3, 2006
• Last Update Posted Date: November 17, 2017
• Study Start Date: October 2005
• Actual Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 26, 2013)

Local progression-free interval in irradiated field [ Time Frame: up to 5 years after randomisation ]

Time form randomisation to tumour progression within the irradiated field

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: March 26, 2013)

• 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 ]

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Low-Dose Radiation Therapy in Treating Patients With Follicular or Marginal Zone Non-Hodgkin's Lymphoma
• Official Title: A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma

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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lymphoma
• Intervention: Radiation: radiation therapy

Study Arms

• Experimental: 4 Gy
  4 Gy in 2 fractions
  Intervention: Radiation: radiation therapy
• Active Comparator: 24 Gy
  24 Gy in 12 fractions
  Intervention: Radiation: radiation therapy

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 26, 2013): 614
• Original Enrollment: Not Provided
• Actual Study Completion Date: January 2017
• Actual Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00310167
• Other Study ID Numbers: UCL/05/84; CRUK-FORT; CRUK-BRD/05/84; 2005-002416-19 ( EudraCT Number ); ISRCTN65687030; EU-20601
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University College, London
• Original Responsible Party: Not Provided
• Current Study Sponsor: University College, London
• Original Study Sponsor: Cancer Research UK
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University College, London
• Verification Date: November 2017