Standardisation of breast radiotherapy (START) trial
| ISRCTN | ISRCTN59368779 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59368779 |
| ClinicalTrials.gov (NCT) | NCT00005588 |
| Protocol serial number | G9600656 |
| Sponsor | Institute of Cancer Research (UK) |
| Funders | Department of Health, Medical Research Council (UK), Cancer Research UK |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Department of Radiotherapy
Royal Marsden Hospital
The Institute of Cancer Research
Downs Road
Sutton
SM2 5PT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Standardisation of breast radiotherapy (START) trial |
| Study acronym | START |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Radiotherapy schedules using fraction sizes larger than 2.0 Gy |
| Intervention type | Other |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 24/10/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 4451 |
| Total final enrolment | 4451 |
| Key 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 |
| Key exclusion criteria | Patients requiring axillary radiotherapy after greater than a level 1 axillary dissection or after greater than 10 lymph nodes have been removed |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 24/10/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
SM2 5PT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | START A | 28/10/2021 | No | Yes | |
| Plain English results | START B | 25/10/2022 | No | Yes | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | 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.
