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

Phase 3

Completed

• Conditions: Lymphoma
• Interventions: Radiation: radiation therapy

• Registration Number: NCT00310167
• Lead Sponsor: University College, London

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 Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-03-29
• Study First Submitted QC: 2006-03-29
• Study First Posted: 2006-04-03
• Primary Completion: 2013-07
• Study Completion: 2017-01
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-16
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 614

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
24 Gy	radiation therapy	24 Gy in 12 fractions
4 Gy	radiation therapy	4 Gy in 2 fractions

Primary Outcome Measures

Name	Time	Method
Local progression-free interval in irradiated field	up to 5 years after randomisation	Time form randomisation to tumour progression within the irradiated field

Secondary Outcome Measures

Name	Time	Method
Health economic assessment	up to 5 years after randomisation
Overall survival	up to 5 years after randomisation
Late toxicity	from 12 weeks after randomisation up to 5 years
Tumor response in irradiated area at 12 weeks after randomization	at 12 weeks after randomization
Acute toxicity	at 4 weeks after randomization

Trial Locations

Locations (1)

Cancer Research UK and University College London Cancer Trials Centre; 🇬🇧 London, England, United Kingdom