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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 29, 2006
Last Updated Date	March 26, 2013
Start Date ^ICMJE	October 2005
Estimated Primary Completion Date	July 2016 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 26, 2013)	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
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00310167 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 26, 2013)	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 ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Low-Dose Radiation Therapy in Treating Patients With Follicular or Marginal Zone Non-Hodgkin's Lymphoma
Official Title ^ICMJE	A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma
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.
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 Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Lymphoma
Intervention ^ICMJE	Radiation: radiation therapy
Study Arm (s)	Experimental: 4 Gy 4 Gy in 2 fractions Intervention: Radiation: radiation therapy Active Comparator: 24 Gy 24 Gy in 12 fractions Intervention: Radiation: radiation therapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	614
Estimated Completion Date	July 2016
Estimated Primary Completion Date	July 2016 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00310167
Other Study ID Numbers ^ICMJE	UCL/05/84, CRUK-FORT, CRUK-BRD/05/84, EUDRACT-2005-002416-19, ISRCTN65687030, EU-20601
Has Data Monitoring Committee	Yes
Responsible Party	University College, London
Study Sponsor ^ICMJE	University College, London
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University College, London
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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