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 (NCT) | NCT00107497 |
| Protocol serial number | N/A |
| Sponsor | Institute of Cancer Research (UK) |
| Funder | 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). |
- 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
Contact information
Prof John Yarnold
Scientific
Scientific
Academic Radiotherapy
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
| Phone | +44 (0)20 8661 3388 |
|---|---|
| john.yarnold@icr.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Change in photographic breast appearance. |
| Key secondary outcome measure(s) |
Tumour recurrence in the breast. |
| Completion date | 09/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 900 |
| 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
- United Kingdom
- England
Study participating centre
Academic Radiotherapy
Sutton
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/10/2021: Publication reference and total final enrolment added.
