Prospective randomised clinical trial testing 5.7 Gy and 6.0 Gy fractions of whole breast radiotherapy in terms of late normal tissue responses and tumour control

ISRCTN	ISRCTN62488883
DOI	https://doi.org/10.1186/ISRCTN62488883
ClinicalTrials.gov number	NCT00107497
Secondary identifying numbers	N/A

Submission date: 01/10/2004
Registration date: 10/01/2005
Last edited: 06/10/2021

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

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-at-different-ways-of-giving-radiotherapy-for-women-with-early-breast-cancer

Study website

Contact information

Prof John Yarnold
Scientific

Academic Radiotherapy
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom

Phone	+44 (0)20 8661 3388
Email	john.yarnold@icr.ac.uk

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	Prospective randomised clinical trial testing 5.7 Gy and 6.0 Gy fractions of whole breast radiotherapy in terms of late normal tissue responses and tumour control
Study acronym	FAST
Study objectives	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(s)	Added 30/07/2008: South West MREC (04/MRE06/17) - approved 30/06/2004.
Health condition(s) or problem(s) studied	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
Primary outcome measure	Change in photographic breast appearance.
Secondary outcome measures	Tumour recurrence in the breast.
Overall study start date	01/10/2004
Completion date	09/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	900 (recruited as of 09/03/2007)
Total final enrolment	915
Key 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
Key exclusion criteria	1. Age less than 50 years 2. Mastectomy 3. Lymphatic radiotherapy or radiotherapy boost 4. Neoadjuvant or adjuvant cytotoxic therapy
Date of first enrolment	01/10/2004
Date of final enrolment	09/03/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Academic Radiotherapy

Sutton
SM2 5PT
United Kingdom

Sponsor information

Institute of Cancer Research (UK)
Research organisation

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Website	http://www.icr.ac.uk/index.shtml
"ROR"	https://ror.org/043jzw605

Funders

Funder type

Charity

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).

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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?
Results article	results	01/07/2011		Yes	No
Results article		14/07/2020	06/10/2021	Yes	No

Editorial Notes

06/10/2021: Publication reference and total final enrolment added.