Low-dose radiation therapy in treating patients with follicular non-Hodgkin's lymphoma
| ISRCTN | ISRCTN65687030 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65687030 |
| ClinicalTrials.gov number | NCT00310167 |
| Secondary identifying numbers | BRD/05/84 |
- Submission date
- 23/05/2005
- Registration date
- 01/12/2005
- Last edited
- 05/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Peter Hoskin
Scientific
Scientific
Centre for Cancer Treatment
Mount Vernon Hospital
Rickmansworth Road
Northwood
Middlesex
HA6 2RN
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A phase III multi-centre randomised controlled trial of low-dose palliative radiotherapy for follicular lymphoma |
| Study acronym | FoRT |
| Study objectives | The palliative treatment of patients with follicular lymphoma with low dose radiation (4 Gy) can produce results that are equal/similar to that of standard dose radiation (24 Gy). On 15/02/2011 this trial record was updated. The anticipated end date was extended from 31/10/2010 to 30/09/2011 and the target participant number was reduced from 650 to 540. |
| Ethics approval(s) | Eastern Multicentre Research Ethics Committee |
| Health condition(s) or problem(s) studied | Non-Hodgkin's follicular lymphoma |
| Intervention | Control arm: radiotherapy dosage of 24 Gy administered in 12 fractions Experimental arm: 4 Gy administered in two consecutive fractions |
| Intervention type | Other |
| Primary outcome measure | Local progression-free interval |
| Secondary outcome measures | 1. Acute toxicity 2. Late toxicity 3. Tumour response 4. Overall survival 5. Health economic assessment |
| Overall study start date | 01/10/2005 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 540 |
| Total final enrolment | 548 |
| Key inclusion criteria | The study population will consist of either male or females over the age of 18 years who are diagnosed with histologically proven follicular lymphoma, for whom palliative radiotherapy has been indicated by virture of tumour bulk or anatomical position. |
| Key exclusion criteria | 1. Stage 1A disease to be treated radically with radiotherapy 2. Histological sub-types other than follicular non-Hodgkin's lymphoma 3. Predicted prognosis less than 3 months 4. Chemotherapy within 4 weeks of planned radiotherapy |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 30/09/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Cancer Treatment
Middlesex
HA6 2RN
United Kingdom
HA6 2RN
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
UCL Biomedicine Research and Development Unit
Hampstead Campus
Rowland Hill Street
London
NW3 2PF
England
United Kingdom
| Website | http://www.ucl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 01/04/2014 | Yes | No | |
| Results article | 5-year follow-up results | 01/03/2021 | 05/02/2021 | Yes | No |
Editorial Notes
05/02/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
