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Completed

NCT Number: NCT00310167

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Research UK and University College London Cancer Trials Centre

London, England, W1T 4TJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiation therapy

Radiation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma

Acronym: FoRT

Important dates

Study start
2005
Primary completion
2013
Study completion
2017
First posted
Apr 3, 2006
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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