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

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

Study Description
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.


Condition or disease Intervention/treatment Phase
Lymphoma Radiation: radiation therapy Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 614 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2005
Primary Completion Date : July 2013
Study Completion Date : January 2017


Arms and Interventions

Arm Intervention/treatment
Experimental: 4 Gy
4 Gy in 2 fractions
Radiation: radiation therapy
Active Comparator: 24 Gy
24 Gy in 12 fractions
Radiation: radiation therapy


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Acute toxicity [ Time Frame: at 4 weeks after randomization ]
  2. Late toxicity [ Time Frame: from 12 weeks after randomisation up to 5 years ]
  3. Tumor response in irradiated area at 12 weeks after randomization [ Time Frame: at 12 weeks after randomization ]
  4. Overall survival [ Time Frame: up to 5 years after randomisation ]
  5. Health economic assessment [ Time Frame: up to 5 years after randomisation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
2005-002416-19 ( EudraCT Number )
ISRCTN65687030
EU-20601
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

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, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell