Condition category
Cancer
Date applied
23/05/2005
Date assigned
01/12/2005
Last edited
10/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Peter Hoskin

ORCID ID

Contact details

Centre for Cancer Treatment
Mount Vernon Hospital
Rickmansworth Road
Northwood
Middlesex
HA6 2RN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00310167

Protocol/serial number

BRD/05/84

Study information

Scientific title

A phase III multi-centre randomised controlled trial of low dose palliative radiotherapy for follicular lymphoma

Acronym

FoRT

Study hypothesis

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

Eastern Multicentre Research Ethics Committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase III

Drug names

Primary outcome measures

Local progression-free interval

Secondary outcome measures

1. Acute toxicity
2. Late toxicity
3. Tumour response
4. Overall survival
5. Health economic assessment

Overall trial start date

01/10/2005

Overall trial end date

30/09/2011

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

540

Participant 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

Recruitment start date

01/10/2005

Recruitment end date

30/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Cancer Treatment
Middlesex
HA6 2RN
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

UCL Biomedicine Research and Development Unit
Hampstead Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24572077

Publication citations

  1. Results

    Hoskin 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, 15, 4, 457-463, doi: 10.1016/S1470-2045(14)70036-1.

Additional files

Editorial Notes