Standardisation of breast radiotherapy (START) trial
| ISRCTN | ISRCTN59368779 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59368779 |
| ClinicalTrials.gov number | NCT00005588 |
| Secondary identifying numbers | G9600656 |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 25/10/2022
- 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
Not provided at time of registration
Contact information
Prof John Yarnold
Scientific
Scientific
Department of Radiotherapy
Royal Marsden Hospital
The Institute of Cancer Research
Downs Road
Sutton
SM2 5PT
United Kingdom
Study information
| Study design | Randomised 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 | Standardisation of breast radiotherapy (START) trial |
| Study 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(s) | Added 30 July 2008: South East London (MREC 98/96) - approved 30/09/1998 |
| Condition | Breast cancer |
| Intervention | Radiotherapy schedules using fraction sizes larger than 2.0 Gy |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/01/1999 |
| Overall study end date | 24/10/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 4451 patients recruited up to 24/10/2002. 5 years follow up |
| Total final enrolment | 4451 |
| 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 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
- England
- United Kingdom
Study participating centre
Department of Radiotherapy
Sutton
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Sponsor information
Institute of Cancer Research (UK)
Research organisation
Research organisation
123 Old Brompton Road
London
SW7 3RP
United Kingdom
| Website | http://www.icr.ac.uk |
|---|---|
"ROR" |
https://ror.org/043jzw605 |
Funders
Funder type
Charity
Department of Health
No information available
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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 | March results on 'Trial A' | 29/03/2008 | Yes | No | |
| Results article | April results on 'Trial B' | 01/04/2008 | Yes | No | |
| Results article | results | 01/03/2010 | Yes | No | |
| Plain English results | START A | 28/10/2021 | No | Yes | |
| Plain English results | START B | 25/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
28/10/2021: Cancer Research UK plain English results link added.
