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

Lymphoma Clinical Trial

— FoRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310167
• Other study ID #: UCL/05/84
• Secondary ID: CRUK-FORTCRUK-BR
• Status: Completed
• Phase: Phase 3
• First received: March 29, 2006
• Last updated: November 16, 2017
• Start date: October 2005
• Est. completion date: January 2017

Study information

• Verified date: November 2017
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 614
• Est. completion date: January 2017
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Follicular

Intervention

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Cancer Research UK and University College London Cancer Trials Centre	London	England

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local progression-free interval in irradiated field	Time form randomisation to tumour progression within the irradiated field	up to 5 years after randomisation
Secondary	Acute toxicity		at 4 weeks after randomization
Secondary	Late toxicity		from 12 weeks after randomisation up to 5 years
Secondary	Tumor response in irradiated area at 12 weeks after randomization		at 12 weeks after randomization
Secondary	Overall survival		up to 5 years after randomisation
Secondary	Health economic assessment		up to 5 years after randomisation