Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
02/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.icr.ac.uk/research/research_sections/clinical_trials/clinical_trials_list/2414_disease.shtml

Contact information

Type

Scientific

Primary contact

Prof John Yarnold

ORCID ID

Contact details

Department of Radiotherapy
Royal Marsden Hospital
The Institute of Cancer Research
Downs Road
Sutton
SM2 5PT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00005588

Protocol/serial number

G9600656

Study information

Scientific title

Acronym

START

Study hypothesis

To test the effects of radiotherapy schedules using fraction sizes larger than 2.0 Gy in terms of normal tissue responses, loco-regional tumour control, quality of life and economic consequences in women prescribed postoperative radiotherapy for early breast cancer.

Ethics approval

Added 30 July 2008: South East London (MREC 98/96) - approved 30/09/1998

Study design

Randomised controlled 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 the contact details below to request a patient information sheet

Condition

Breast cancer

Intervention

Radiotherapy schedules using fraction sizes larger than 2.0 Gy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

In this study several endpoints are being investigated (tumour recurrence, normal tissue effect, quality of life). It is intended that each will be analysed separately. If there is discordance between the endpoints in terms of treatment outcome this will allow discussion of clinical trade-offs. In a subset of patients there will be a detailed assessment of quality of life. Health economic consequences will also be determined.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1999

Overall trial end date

24/10/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients must be 18 years and above, have operable unilateral breast cancer (T1-3, NO-1, MO at presentation)
2. There must be histological confirmation of invasive carcinoma and complete macroscopic excision of tumour by breast conserving surgery or mastectomy
3. The patient must consent to be part of the study and be available for follow-up

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

4451 patients recruited up to 24/10/2002. 5 years follow up

Participant exclusion criteria

Patients requiring axillary radiotherapy after greater than a level 1 axillary dissection or after greater than 10 lymph nodes have been removed

Recruitment start date

01/01/1999

Recruitment end date

24/10/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Radiotherapy
Sutton
SM2 5PT
United Kingdom

Sponsor information

Organisation

Institute of Cancer Research (UK)

Sponsor details

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Sponsor type

Research organisation

Website

http://www.icr.ac.uk

Funders

Funder type

Charity

Funder name

Department of Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. March 2008 results on 'Trial A' in http://www.ncbi.nlm.nih.gov/pubmed/18355913
2. April 2008 results on 'Trial B' in http://www.ncbi.nlm.nih.gov/pubmed/18356109
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20138809

Publication citations

  1. Results

    Hopwood P, Haviland JS, Sumo G, Mills J, Bliss JM, Yarnold JR, , Comparison of patient-reported breast, arm, and shoulder symptoms and body image after radiotherapy for early breast cancer: 5-year follow-up in the randomised Standardisation of Breast Radiotherapy (START) trials., Lancet Oncol., 2010, 11, 3, 231-240, doi: 10.1016/S1470-2045(09)70382-1.

  2. , Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bentzen SM, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR, The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial., Lancet, 2008, 371, 9618, 1098-1107, doi: 10.1016/S0140-6736(08)60348-7.

  3. , Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR, The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial., Lancet Oncol., 2008, 9, 4, 331-341, doi: 10.1016/S1470-2045(08)70077-9.

Additional files

Editorial Notes