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

Last updated: November 16, 2017
Sponsor: University College, London
Overall Status: Completed

Phase

3

Condition

Marginal Zone Lymphoma

Lymphoma, B-cell

Follicular Lymphoma

Treatment

N/A

Clinical Study ID

NCT00310167
UCL/05/84
ISRCTN65687030
EU-20601
CRUK-BRD/05/84
2005-002416-19
CRUK-FORT
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 614
Study Start date:
October 01, 2005
Estimated Completion Date:
January 31, 2017

Study 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.

Connect with a study center

  • Cancer Research UK and University College London Cancer Trials Centre

    London, England W1T 4TJ
    United Kingdom

    Site Not Available

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