Condition category
Cancer
Date applied
01/10/2004
Date assigned
10/01/2005
Last edited
28/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof John Yarnold

ORCID ID

Contact details

Academic Radiotherapy
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
+44 (0)20 8661 3388
john.yarnold@icr.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00814567

Protocol/serial number

N/A

Study information

Scientific title

Acronym

FAST

Study hypothesis

Aim: to test 5 fractions of 5.7 Gy and 6.0 Gy against 25 fractions of 2.0 Gy in terms of late normal tissue effects and tumour control in women prescribed whole breast radiotherapy (no boost) after local excision of early breast cancer.

Ethics approval

Added 30/07/2008: South West MREC (04/MRE06/17) - approved 30/06/2004.

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

Early breast cancer

Intervention

Control arm: 50 Gy in 25 fractions over 5 weeks
Test arm 1: 30 Gy in 5 fractions over 5 weeks
Test arm 2: 28.5 Gy in 5 fractions over 5 weeks

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Change in photographic breast appearance.

Secondary outcome measures

Tumour recurrence in the breast.

Overall trial start date

01/10/2004

Overall trial end date

09/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women over the age of 49 years with invasive breast cancer who have had breast preserving surgery
2. Tumour size less than 3 cm with complete resection and node negative

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

900 (recruited as of 09/03/2007)

Participant exclusion criteria

1. Age less than 50 years
2. Mastectomy
3. Lymphatic radiotherapy or radiotherapy boost
4. Neoadjuvant or adjuvant cytotoxic therapy

Recruitment start date

01/10/2004

Recruitment end date

09/03/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Radiotherapy
Sutton
SM2 5PT
United Kingdom

Sponsor information

Organisation

Institute of Cancer Research (UK)

Sponsor details

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Sponsor type

Research organisation

Website

http://www.icr.ac.uk/index.shtml

Funders

Funder type

Charity

Funder name

Research costs are covered by the Cancer Research UK (CRUK) core grant held by the Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21752481

Publication citations

  1. Results

    , Agrawal RK, Alhasso A, Barrett-Lee PJ, Bliss JM, Bliss P, Bloomfield D, Bowen J, Brunt AM, Donovan E, Emson M, Goodman A, Harnett A, Haviland JS, Kaggwa R, Morden JP, Robinson A, Simmons S, Stewart A, Sydenham MA, Syndikus I, Tremlett J, Tsang Y, Wheatley D, Venables K, Yarnold JR, First results of the randomised UK FAST Trial of radiotherapy hypofractionation for treatment of early breast cancer (CRUKE/04/015)., Radiother Oncol, 2011, 100, 1, 93-100, doi: 10.1016/j.radonc.2011.06.026.

Additional files

Editorial Notes