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:
University College, London
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
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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 (24Gy versus 4Gy) to compare how well they work in treating patients with follicular or marginal zone non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma |
Resource links provided by NLM:
Further study details as provided by University College, London:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 614 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 4 Gy
4 Gy in 2 fractions
|
Radiation: radiation therapy |
|
Active Comparator: 24 Gy
24 Gy in 12 fractions
|
Radiation: radiation therapy |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | University College, London |
| ClinicalTrials.gov Identifier: | NCT00310167 History of Changes |
| Other Study ID Numbers: | UCL/05/84, CRUK-FORT, CRUK-BRD/05/84, EUDRACT-2005-002416-19, ISRCTN65687030, EU-20601 |
| Study First Received: | March 29, 2006 |
| Last Updated: | March 26, 2013 |
| Health Authority: | United Kingdom: NHS Health Research Authority |
Keywords provided by University College, London:
|
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 Marginal zone lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, B-Cell, Marginal Zone Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell |
ClinicalTrials.gov processed this record on May 16, 2013