Condition category
Cancer
Date applied
18/05/2011
Date assigned
31/05/2011
Last edited
29/01/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Prof John Yarnold

ORCID ID

Contact details

Academic Radiotherapy
Orchard House
Downs Road
Sutton
SM2 5PT
United Kingdom
john.yarnold@icr.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 09/01/47, ICR-CTSU/2010210026

Study information

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

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

Approval pending as of 20/05/2011

Study design

Phase III randomised controlled multi centre 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 contact details below to request a patient information sheet

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 - 40Gy in 15 fractions over 15 days (not weekends)
Test group 1 - 27Gy in 5 fractions over 5 days (not weekends)
Test group 2 - 26Gy 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

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

01/09/2011

Overall trial end date

01/09/2025

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

4000

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

01/09/2025

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Radiotherapy
Sutton
SM2 5PT
United Kingdom

Sponsor information

Organisation

The Institute of Cancer Research (UK)

Sponsor details

123 Old Brompton Road
London
SW7 3PR
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) (09/01/47)

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

Publication citations

Additional files

Editorial Notes