Low-dose radiation therapy in treating patients with follicular non-Hodgkin's lymphoma
| ISRCTN | ISRCTN65687030 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65687030 |
| ClinicalTrials.gov (NCT) | NCT00310167 |
| Protocol serial number | BRD/05/84 |
| Sponsor | University College London (UK) |
| Funder | Cancer Research UK (CRUK) (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Local progression-free interval |
| Key secondary outcome measure(s) |
1. Acute toxicity |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Centre for Cancer Treatment
Middlesex
HA6 2RN
United Kingdom
HA6 2RN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2014 | Yes | No | |
| Results article | 5-year follow-up results | 01/03/2021 | 05/02/2021 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes | |||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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)
