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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT00310167
First received: March 29, 2006
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Lymphoma
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Local progression-free interval in irradiated field [ Time Frame: up to 5 years after randomisation ] [ Designated as safety issue: No ]
    Time form randomisation to tumour progression within the irradiated field


Secondary Outcome Measures:
  • Acute toxicity [ Time Frame: at 4 weeks after randomization ] [ Designated as safety issue: Yes ]
  • Late toxicity [ Time Frame: from 12 weeks after randomisation up to 5 years ] [ Designated as safety issue: Yes ]
  • Tumor response in irradiated area at 12 weeks after randomization [ Time Frame: at 12 weeks after randomization ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to 5 years after randomisation ] [ Designated as safety issue: No ]
  • Health economic assessment [ Time Frame: up to 5 years after randomisation ] [ Designated as safety issue: No ]

Enrollment: 614
Study Start Date: October 2005
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4 Gy
4 Gy in 2 fractions
Radiation: radiation therapy
Active Comparator: 24 Gy
24 Gy in 12 fractions
Radiation: radiation therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310167

Locations
United Kingdom
Cancer Research UK and University College London Cancer Trials Centre
London, England, United Kingdom, W1T 4TJ
Sponsors and Collaborators
University College, London
  More Information

Additional Information:
No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT00310167     History of Changes
Other Study ID Numbers: UCL/05/84, CRUK-FORT, CRUK-BRD/05/84, EUDRACT-2005-002416-19, ISRCTN65687030, EU-20601
Study First Received: March 29, 2006
Last Updated: March 26, 2013
Health Authority: United Kingdom: NHS Health Research Authority

Keywords provided by University College, London:
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell

ClinicalTrials.gov processed this record on April 21, 2014