LymphomaPhase 3FoRTNCT00310167
Low-Dose Radiation Therapy in Treating Patients With Follicular or Marginal Zone Non-Hodgkin's Lymphoma
A Phase 3 study testing radiation therapy in people with Lymphoma, run by University College, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2005to Jan 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cancer Research UK and University College London Cancer Trials Centre
London, England, W1T 4TJ
About this study
Official title: A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma
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.
Read the 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.
- Conditions
- Lymphoma
- Being tested
- radiation therapy
- Keywords
- 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
- Medical subject headings
- Lymphoma, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| 4 Gy | Experimental | 4 Gy in 2 fractions Receives: Radiation: radiation therapy |
| 24 Gy | Active comparator | 24 Gy in 12 fractions Receives: Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local progression-free interval in irradiated field
Time form randomisation to tumour progression within the irradiated field
Measured: up to 5 years after randomisation
Secondary outcomes (5)
Acute toxicity
Measured: at 4 weeks after randomization
Late toxicity
Measured: from 12 weeks after randomisation up to 5 years
Tumor response in irradiated area at 12 weeks after randomization
Measured: at 12 weeks after randomization
Overall survival
Measured: up to 5 years after randomisation
Health economic assessment
Measured: up to 5 years after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startOct 2005
- Primary completionJul 2013
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310167
- Sponsor's protocol ID
- UCL/05/84
- Other IDs
- CRUK-FORT, CRUK-BRD/05/84, 2005-002416-19, ISRCTN65687030, EU-20601, 2005
- Acronym
- FoRT
- Status last verified
- Nov 2017
- First submitted
- 29 Mar 2006
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoskin P, Popova B, Schofield O, Brammer C, Robinson M, Brunt AM, Madhavan K, Illidge T, Gallop-Evans E, Syndikus I, Clifton-Hadley L, Kirkwood AA. 4 Gy versus 24 Gy radiotherapy for follicular and marginal zone lymphoma (FoRT): long-term follow-up of a multicentre, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2021 Mar;22(3):332-340. doi: 10.1016/S1470-2045(20)30686-0. Epub 2021 Feb 1.
PubMed 33539729Hoskin PJ, Kirkwood AA, Popova B, Smith P, Robinson M, Gallop-Evans E, Coltart S, Illidge T, Madhavan K, Brammer C, Diez P, Jack A, Syndikus I. 4 Gy versus 24 Gy radiotherapy for patients with indolent lymphoma (FORT): a randomised phase 3 non-inferiority trial. Lancet Oncol. 2014 Apr;15(4):457-63. doi: 10.1016/S1470-2045(14)70036-1. Epub 2014 Feb 24.
PubMed 24572077
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma
- ClinicalTrials.gov ID
- NCT00310167
- Acronym / sponsor ID
- FoRT / UCL/05/84
- Conditions
- Lymphoma
- Keywords
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 3 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 Gy | Experimental | Radiation: radiation therapy4 Gy in 2 fractions |
| 24 Gy | Active comparator | Radiation: radiation therapy24 Gy in 12 fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiation therapy | Radiation | 24 Gy, 4 Gy |
Primary outcome
Local progression-free interval in irradiated field
Time frame: up to 5 years after randomisation
Time form randomisation to tumour progression within the irradiated field
5 secondary outcomes
Acute toxicity
Time frame: at 4 weeks after randomization
Late toxicity
Time frame: from 12 weeks after randomisation up to 5 years
Tumor response in irradiated area at 12 weeks after randomization
Time frame: at 12 weeks after randomization
Overall survival
Time frame: up to 5 years after randomisation
Health economic assessment
Time frame: up to 5 years after randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 33539729Hoskin P, Popova B, Schofield O, Brammer C, Robinson M, Brunt AM, Madhavan K, Illidge T, Gallop-Evans E, Syndikus I, Clifton-Hadley L, Kirkwood AA. 4 Gy versus 24 Gy radiotherapy for follicular and marginal zone lymphoma (FoRT): long-term follow-up of a multicentre, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2021 Mar;22(3):332-340. doi: 10.1016/S1470-2045(20)30686-0. Epub 2021 Feb 1.
- Derived from this study: PubMed 24572077Hoskin PJ, Kirkwood AA, Popova B, Smith P, Robinson M, Gallop-Evans E, Coltart S, Illidge T, Madhavan K, Brammer C, Diez P, Jack A, Syndikus I. 4 Gy versus 24 Gy radiotherapy for patients with indolent lymphoma (FORT): a randomised phase 3 non-inferiority trial. Lancet Oncol. 2014 Apr;15(4):457-63. doi: 10.1016/S1470-2045(14)70036-1. Epub 2014 Feb 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing radiation therapy in people with Lymphoma, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local progression-free interval in irradiated field (time frame: up to 5 years after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00310167, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.