Can we safely reduce the number of days of radiotherapy needed to treat people with breast cancer who need boost treatment?
| ISRCTN | ISRCTN13849110 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13849110 |
| IRAS number | 341881 |
| Secondary identifying numbers | CPMS 57885, NIHR157800, ICR_CTSU/2024/10088 |
- Submission date
- 19/02/2025
- Registration date
- 03/03/2025
- Last edited
- 03/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Background and study aims
Each year, 37,000 people in the UK with breast cancer receive radiotherapy, which uses radiation to kill cancer cells. Most people can now be treated over 5 days, but about 10,000 still need up to 23 days of treatment because they require an extra dose called a boost. This study aims to find out if the boost can be given within a 5-day radiotherapy course, comparing two different boost doses over 5 days with the standard 15-day boost dose.
Who can participate?
People with breast cancer who need a boost dose as part of their radiotherapy treatment can participate. Participants will be invited from 50 UK radiotherapy centres.
What does the study involve?
Participants will be randomly placed into one of three groups by a computer:
One group will receive the boost dose over 15 days.
Two groups will receive the boost dose over 5 days, with different boost doses for each group. Participants will provide information about side effects, changes to the treated breast, extreme tiredness, and quality of life for five years.
What are the possible benefits and risks of participating? The study aims to show that the 5-day treatment is as effective as the 15-day treatment in preventing cancer from returning, with the same or fewer side effects and faster recovery. Risks include potential side effects from radiotherapy and the possibility that the shorter treatment may not be as effective.
Where is the study run from?
Institute of Cancer Research - Clinical Trials and Statistics Unit (UK).
When is the study starting and how long is it expected to run for?
April 2025 to September 2033
Who is funding the study?
The study is funded by the National Institute for Health and Care Research - Health Technology Assessment (NIHR-HTA) programme (UK).
Who is the main contact?
Institute of Cancer Research - Clinical Trials and Statistics Unit
fastforwardboost-icrctsu@icr.ac.uk
Contact information
Prof Judith Bliss
Scientific
Scientific
ICR-CTSU
Sir Richard Doll Building
The Institute of Cancer Research
Cotswold Road
Sutton
SM2 5NG
United Kingdom
| Phone | +44 208 722 4104 |
|---|---|
| Fastforwardboost-icrctsu@icr.ac.uk |
Dr Anna Kirby
Principal Investigator
Principal Investigator
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
 ORCID ID |
0000-0002-5528-1669 |
|---|---|
| Phone | +44 2087224104 |
| anna.kirby@rmh.nhs.uk |
Mr Mark Sydenham
Public
Public
ICR-CTSU
Sir Richard Doll Building
The Institute of Cancer Research
Cotswold Road
Sutton
SM2 5NG
United Kingdom
| ORCID ID |
0000-0002-9157-9710 |
|---|---|
| Phone | +44 208 722 4104 |
| fastforwardboost-icrctsu@icr.ac.uk |
Study information
| Study design | Phase III multi-centre randomized 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 | A randomised clinical trial testing a 1-week schedule of curative simultaneous integrated boost radiotherapy against a standard 3-week schedule in patients with early breast cancer |
| Study acronym | FAST-Forward Boost |
| Study hypothesis | Local recurrence rates at 5-years will be no higher with appropriately dosed 1-week Simultaneous Integrated Boost radiotherapy (SIB RT) than with 3-week SIB radiotherapy and that this can be achieved without an increase in normal tissue side-effects |
| Ethics approval(s) |
Approved 14/01/2025, London - South East REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8222; londonsoutheast.rec@hra.nhs.uk), ref: 24/LO/0910 |
| Condition | Breast cancer |
| Intervention | Patients will be treated using standard radiotherapy to the breast +/- nodes with a SIB to the tumour bed and randomised on a 1:1:1 basis to one of the following schedules: • Standard radiotherapy to the breast +/- nodes using a schedule of 40Gy/15Fr over 3 weeks with a 48Gy/15Fr simultaneous integrated boost (SIB) of the tumour bed (Control Group) • 26Gy/5Fr over 1 week with a 31Gy/5Fr SIB (Test Group 1) • 26Gy/5Fr over 1 week with a 30Gy/5Fr SIB (Test Group 2) Radiotherapy treatment All patients will attend the radiotherapy department for a planning CT scan so their radiotherapy treatment can be planned. Once the treatment has been planned. The patient will start their radiotherapy treatment. Treatment is usually given daily on week days. Those in the control group will have their radiotherapy treatment in 15 treatments, the test groups will have their radiotherapy in 5 treatments. Questionnaires For those taking part in the early side-effects sub-study, questionnaires about side-effects will need to be completed by the patient prior to radiotherapy, weekly for 7 weeks from start of radiotherapy and at 3 months. All patients will be asked to complete questionnaire booklets pre treatment and at weeks 1, 3 and 5 from the start of radiotherapy then at 3 months, 1, 2, 3, 4 and 5 years. Follow up For those taking part in the early side-effects sub-study: Control group: will also be reviewed at weeks 1, 3, 5 and 7 from the start of radiotherapy Test Groups: will also be reviewed at weeks 1, 3, 5 and 7 from the start of radiotherapy All patients will be reviewed by the clinical team at 3 months, 1 years, 3 years and at 5 years. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Ipsilateral breast tumour recurrence (IBTR) measured using patient records at 5 years |
| Secondary outcome measures | 1. Patient-reported acute radiotherapy adverse effects, with a focus on skin, breast, and oesophageal effects, are measured using PRO-CTCAE and trial-specific questionnaires at baseline, weekly for 7 weeks from the start of radiotherapy, and at 3 months 2. Patient-reported late effects on quality of life, with a focus on breast symptoms and shoulder/arm functioning, are measured using EORTC QLQ BR-23 and trial-specific questionnaires at baseline, weeks 1, 3, and 5 from the start of radiotherapy, and at 3 months, 1, 2, 3, 4, and 5 years 3. Patient-reported fatigue is measured using EORTC QLQ FA-12 at baseline, weeks 1, 3, and 5 from the start of radiotherapy, and at 3 months, 1, 2, 3, 4, and 5 years 4. Health-related quality of life is measured using EORTC QLQ C-30 and EQ5D-5L at baseline, weeks 1, 3, and 5 from the start of radiotherapy, and at 3 months, 1, 2, 3, 4, and 5 years 5. Body image is measured using the Body Image Scale (BIS) at baseline, weeks 1, 3, and 5 from the start of radiotherapy, and at 3 months, 1, 2, 3, 4, and 5 years 6. Clinician-reported acute radiotherapy adverse effects, with a focus on skin, oesophageal, and lung toxicity, are measured using CTCAE v5.0 and RTOG at baseline, weekly for 7 weeks from the start of radiotherapy, and at 3 months 7. Clinician-reported breast oedema is measured using trial-specific tools at baseline, weekly for 7 weeks from the start of radiotherapy, and at 3 months 8. Clinician-reported late radiotherapy adverse effects, with a focus on normal tissue effects and cosmesis, are measured using tools developed in previous breast radiotherapy trials and the Harvard-Harris scale at baseline, 3 months, 1, 3, and 5 years 9. Clinician-reported lung toxicity is measured using RTOG at baseline, 3 months, 1, 3, and 5 years 10. Recurrence-free survival, breast cancer-related survival, and overall survival are measured using NHS routinely collected data at baseline, 3 months, 1, 3, and 5 years 11. Cost-effectiveness is measured using health economic analysis incorporating data on patient-reported health resource use, out-of-pocket expenses, and health status (EQ5D-5L) at baseline, 3 months, 1, 3, and 5 years |
| Overall study start date | 14/01/2025 |
| Overall study end date | 30/09/2033 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 4,830 |
| Participant inclusion criteria | 1. Age >=18 years 2. Histologically confirmed breast cancer (T1-T3, N0-3, M0) (multifocal disease is allowed) requiring a tumour bed boost plus whole breast radiotherapy +/- radiotherapy to nodes* (axilla +/- internal mammary chain) or DCIS (Tis, N0-3, M0) requiring a tumour bed boost according to local centre policy 3. Treated with breast conservation surgery 4. Complete microscopic resection (invasive cancer and/or DCIS clear of ink on radial margins or, if at margin, surgeon confirms no further breast tissue to excise) 5. Patient can provide informed consent * Axilla levels as per MDM recommendation NB Patients with synchronous bilateral breast cancer can be included as long as the disease on at least one side fulfils the inclusion criteria above. Where the patient has synchronous bilateral disease and needs a tumour bed boost on both sides, both sides will need to fulfil the inclusion criteria for the patient to be eligible for the trial |
| Participant exclusion criteria | 1. Treated with ipsilateral mastectomy 2. Previous radiotherapy to ipsilateral chest area that precludes delivery of a radical dose of adjuvant radiotherapy to the breast with tumour bed boost. NB for any scenarios where there is overlap with previous radiotherapy approval must be sought from the FAST-Forward Boost trial team prior to randomisation 3. Presence of metastatic disease 4. Unavailable for any trial related follow-up 5. History of malignancy except non-melanomatous skin cancer, CIS cervix, previously unirradiated precancerous changes in the breast (including ductal carcinoma in-situ and lobular carcinoma in-situ), and non-breast malignancy if curative intent and at least 5 years disease free 6. Pregnant and/or currently breast feeding 7. Participating in the PARABLE trial |
| Recruitment start date | 01/04/2025 |
| Recruitment end date | 30/09/2028 |
Locations
Countries of recruitment
- England
- Ireland
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Royal Marsden Hospital
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
Downs Road
Sutton
SM2 5PT
United Kingdom
The Royal Marsden Hospital (london)
Fulham Road
London
SW3 6JJ
United Kingdom
London
SW3 6JJ
United Kingdom
The Christie
550 Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
Withington
Manchester
M20 4BX
United Kingdom
Addenbrookes
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
Glasgow
G12 0YN
United Kingdom
Belfast City Hospital
51 Lisburn Rd
Belfast
BT9 7AB
United Kingdom
Belfast
BT9 7AB
United Kingdom
Bristol Haematology & Oncology Centre
Horfield Road
Bristol
BS2 8ED
United Kingdom
Bristol
BS2 8ED
United Kingdom
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
London
W6 8RF
United Kingdom
Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom
Cheltenham
GL53 7AN
United Kingdom
Churchill Hospital
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Clatterbridge Cancer Centre
Clatterbridge Hospital
Clatterbridge Road
Wirral
CH63 4JY
United Kingdom
Clatterbridge Road
Wirral
CH63 4JY
United Kingdom
Derriford Hospital
Derriford Road
Crownhill
Plymouth
PL6 8DH
United Kingdom
Crownhill
Plymouth
PL6 8DH
United Kingdom
Colchester General Hospital
Turner Road
Colchester
CO4 5JL
United Kingdom
Colchester
CO4 5JL
United Kingdom
Guys Hospital
Guys Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Great Maze Pond
London
SE1 9RT
United Kingdom
Ipswich Hospital
Heath Road
Ipswich
IP4 5PD
United Kingdom
Ipswich
IP4 5PD
United Kingdom
South Tees Hospitals NHS Foundation Trust
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Leicester
LE1 5WW
United Kingdom
United Lincolnshire Teaching Hospitals NHS Trust
Lincoln County Hospital
Greetwell Road
Lincoln
LN2 5QY
United Kingdom
Greetwell Road
Lincoln
LN2 5QY
United Kingdom
Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
Northwood
HA6 2RN
United Kingdom
Musgrove Park Hospital (taunton)
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
Taunton
TA1 5DA
United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Glan Clwyd General Hospital NHS Trust
Ysbyty Glan Clwyd
Sarn Lane
Bodelwyddan
LL18 5UJ
United Kingdom
Sarn Lane
Bodelwyddan
LL18 5UJ
United Kingdom
Nottingham University Hospitals NHS Trust - City Campus
Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Peterborough City Hospital
Edith Cavell Campus
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
Queen Alexandras Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
Cosham
Portsmouth
PO6 3LY
United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
Queens Hospital
Rom Valley Way
Romford
RM7 0AG
United Kingdom
Rom Valley Way
Romford
RM7 0AG
United Kingdom
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
Reading
RG1 5AN
United Kingdom
Royal Devon University Healthcare NHS Foundation Trust
Royal Devon University NHS Ft
Barrack Road
Exeter
EX2 5DW
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Royal Free London NHS Foundation Trust
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Royal Preston Hospital
Sharoe Green Lane
Preston
PR2 9HT
United Kingdom
Sharoe Green Lane
Preston
PR2 9HT
United Kingdom
Royal Surrey County Hospital Guildford
Egerton Road
Guildford
GU2 7XX
United Kingdom
Guildford
GU2 7XX
United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
Eastern Road
Brighton
BN2 5BE
United Kingdom
Singleton Hospital
Sketty Lane
Sketty
Swansea
SA2 8QA
United Kingdom
Sketty
Swansea
SA2 8QA
United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Barts and the London NHS Trust
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
Whitechapel
London
E1 1BB
United Kingdom
Leeds Teaching Hospitals NHS Trust
St. James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Walsgrave General Hospital
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Velindre Cancer Centre
Velindre Road
Cardiff
CF14 2TL
United Kingdom
Cardiff
CF14 2TL
United Kingdom
Western General Hospital
Crewe Road South
Edinburgh
Lothian
EH4 2XU
United Kingdom
Edinburgh
Lothian
EH4 2XU
United Kingdom
Weston Park Hospital NHS Trust
Whitham Road
Sheffield
S10 2SJ
United Kingdom
Sheffield
S10 2SJ
United Kingdom
Worcestershire Acute Hospitals NHS Trust
Worcestershire Royal Hospital
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom
Sponsor information
Institute of Cancer Research
Research organisation
Research organisation
123 Old Brompton Road
London
SW7 3RP
England
United Kingdom
| Phone | +44 2073528133 |
|---|---|
| RDCCR@rmh.nhs.uk | |
| Website | https://www.icr.ac.uk/ |
"ROR" |
https://ror.org/00dpztj76 |
Funders
Funder type
Government
National Institute for Health and Care Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The main trial results will be published in a peer-reviewed journal, on behalf of all collaborators. The manuscript will be prepared by a writing group, consisting of members of the TMG. Participating clinicians may be selected to join the writing group on the basis of intellectual and time input. All participating clinicians will be acknowledged in the publication. Any presentations and publications relating to the trial must be authorised by the TMG. Authorship of any secondary publications e.g. those relating to sub-studies, will reflect intellectual and time input into these studies. Authorship of all publication will usually be in accordance with ICMJE guidance. No investigator may present or attempt to publish data relating to the FAST-Forward Boost trial without prior permission from the TMG. It is an expectation that all publications relating to the trial are published as “open-access”. Trial updates and reports on published results will also be on the FAST-Forward Boost trial website for participants and everyone to access. |
| IPD sharing plan | Not provided at time of registration |
Editorial Notes
19/02/2025: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
