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Low-Dose Radiation Therapy in Treating Patients With Follicular Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2008
First Received: March 29, 2006   Last Updated: February 6, 2009   History of Changes
Sponsored by: Mount Vernon Cancer Centre at Mount Vernon Hospital
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00310167
  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 to compare how well they work in treating patients with follicular non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Radiation: radiation therapy
Phase III

MedlinePlus related topics: Cancer Lymphoma Radiation Therapy
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Local progression-free interval every 12 weeks for 2 years after randomization and then every 24 weeks for 3 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute toxicity at 4 weeks after randomization [ Designated as safety issue: Yes ]
  • Late toxicity at 12 weeks after randomization [ Designated as safety issue: Yes ]
  • Tumor response at 12 weeks after randomization [ Designated as safety issue: No ]
  • Overall survival every 12 weeks for 2 years after randomization and then every 24 weeks for 3 years [ Designated as safety issue: No ]
  • Health economic assessment every 12 weeks for 2 years after randomization and then every 24 weeks for 3 years [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: October 2005
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 : Patients undergo low-dose radiotherapy once daily on days 1 and 2.
  • Arm II : 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 periodically for 5 years and then annually thereafter.

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 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, England
Cancer Research UK and University College London Cancer Trials Centre Recruiting
London, England, United Kingdom, W1T 4TJ
Contact: Pip Patrick, MD     44-207-679-9056        
Sponsors and Collaborators
Mount Vernon Cancer Centre at Mount Vernon Hospital
Investigators
Study Chair: Pip Patrick, MD Cancer Research UK
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000468007, CRUK-FORT, CRUK-BRD/05/84, EUDRACT-2005-002416-19, ISRCTN65687030, EU-20601
Study First Received: March 29, 2006
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00310167     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, Follicular
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Follicular Lymphoma
Lymphoma
Recurrence

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

ClinicalTrials.gov processed this record on May 07, 2009