A clinical trial testing a one week schedule of whole breast radiotherapy against a three week schedule
| ISRCTN | ISRCTN19906132 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19906132 |
| IRAS number | 58575 |
| Secondary identifying numbers | HTA 09/01/47, ICR-CTSU/2010210026, IRAS 58575, NIHR150755 |
- Submission date
- 18/05/2011
- Registration date
- 31/05/2011
- Last edited
- 23/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Prof Murray Brunt
Scientific
Scientific
School of Medicine
Keele University
Newcastle
ST5 5BG
United Kingdom
| Phone | +44 (0)208 722 4104 |
|---|---|
| m.brunt@keele.ac.uk |
Study information
| Study design | Phase III randomized controlled multi centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | https://www.icr.ac.uk/our-research/centres-and-collaborations/centres-at-the-icr/clinical-trials- and-statistics-unit/clinical-trials/fast_forward_page |
| Scientific title | Randomised clinical trial testing a one week course of curative whole breast radiotherapy against a standard three week schedule in terms of local cancer control and late adverse effects in patients with early breast cancer |
| Study acronym | FAST-Forward |
| Study hypothesis | To identify a 5-fraction schedule of curative radiotherapy delivered in one week that is at least as effective and safe as the UK standard 15-fraction regimen after primary surgery for early breast cancer. |
| Ethics approval(s) | Approved 02/09/2011, NRES Committee South East Coast - Kent (now London - Brighton and Sussex REC, Ground Floor, Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)207 104 8241; brightonandsussex.rec@hra.nhs.uk), REC ref: 11-LO-0958 |
| Condition | Breast cancer |
| Intervention | Patients will be randomised equally between a standard 3-week schedule and two 1 week test schedules of whole breast radiotherapy Whole breast radiotherapy schedules: Standard group - 40 Gy in 15 fractions over 15 days (not weekends) Test group 1 - 27 Gy in 5 fractions over 5 days (not weekends) Test group 2 - 26 Gy in 5 fractions over 5 days (not weekends) Patients will be followed up for a minimum of 10 years. There are Quality of Life and a photographic sub-studies, each with 2196 patients. Quality of Life questionnaires will be completed at baseline, 6, months and 2, 5 and 10 years post randomisation. Photographs will be taken at baseline and 2, 5 and 10 years post randomisation. |
| Intervention type | Other |
| Primary outcome measure | Ipsilateral local tumour control: Will be reported at the annual follow up visits. The tests will be performed when the need arises i.e. when the patient feels unwell or reports another lump etc. The tests will be carried out as routine clinical examinations i.e. X rays, computerised tomography (CT) scans, magnetic resonance imaging (MRI), ultrasound. |
| Secondary outcome measures | 1. Early and late adverse effects in normal tissues 2. Quality of life at baseline, 6, months and 2, 5 and 10 years post randomisation 3. Contralateral primary tumours, regional and distant metastases 4. Survival |
| Overall study start date | 01/09/2011 |
| Overall study end date | 02/10/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 4600 |
| Total final enrolment | 4579 |
| Participant inclusion criteria | 1. Age more than or equal to 18 years 2. Female or male 3. Invasive carcinoma of the breast 4. Breast conservation surgery or mastectomy (reconstruction allowed but not with implant. Tissue expanders with distant metal ports are allowed) 5. Axillary staging and/or dissection 6. Complete microscopic excision of primary tumour 7. Stage pT1-3 pN0-1 M0 disease 8. Written informed consent 9. Able to comply with follow up Concurrent trastuzumab and hormone therapy is allowed |
| Participant exclusion criteria | 1. Past history of malignancy except basal cell skin cancer and cervical intraepithelial neoplasia (CIN) or non-breast malignancy allowed if treated with curative intent and at least 5 years disease free 2. Contralateral breast cancer, including ductal carcinoma in-situ (DCIS), irrespective of date of diagnosis 3. Breast reconstruction using implants 4. Concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic therapy allowed) 5. Radiotherapy to any regional lymph node areas (excepting lower axilla included in standard tangential fields to breast/chest wall) |
| Recruitment start date | 01/09/2011 |
| Recruitment end date | 02/10/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Radiotherapy
Sutton
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Sponsor information
Institute of Cancer Research
Research organisation
Research organisation
123 Old Brompton Road
London
SW7 3PR
United Kingdom
"ROR" |
https://ror.org/00dpztj76 |
|---|
Funders
Funder type
Government
Health Technology Assessment Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/05/2020 | 26/06/2020 | Yes | No |
| Plain English results | 03/05/2022 | No | Yes | ||
| Results article | 01/11/2023 | 23/11/2023 | Yes | No |
Editorial Notes
23/11/2023: Publication reference added.
10/11/2023: Current Funder ID added.
03/05/2022: added link to plain English results.
07/10/2021: Contact details updated.
06/10/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/09/2025 to 02/10/2018.
2. The overall trial end date was changed from 01/09/2025 to 02/10/2028.
3. Trial website and ethics approval details added.
4. The target number of participants was changed from 4000 to 4600.
5. The total final enrolment was changed from 4096 to 4579.
26/06/2020: Publication reference and total final enrolment number added.
