Sequencing of Chemotherapy and Radiotherapy in Adjuvant Breast cancer
| ISRCTN | ISRCTN84214355 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84214355 |
| ClinicalTrials.gov (NCT) | NCT00003893 |
| Protocol serial number | BR3015 |
| Sponsor | University Hospitals Birmingham NHS Foundation Trust (UK) |
| Funder | Cancer Research UK (UK) |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 25/01/2019
- 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 of protocol
Not provided at time of registration
Contact information
Dr Sarah Bowden
Scientific
Scientific
CRUK Clinical Trials Unit
Institute for Cancer Studies
The University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 4371 |
|---|---|
| BTT@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Sequencing of Chemotherapy and Radiotherapy in Adjuvant Breast cancer |
| Study acronym | SECRAB |
| Study objectives | To answer reliably two questions in the timing of delivery of chemotherapy and radiotherapy in the adjuvant treatment of early breast cancer: 1. Can local control be improved by synchronous delivery of adjuvant chemotherapy and radiotherapy thereby not delaying the administration of either modality? 2. Can synchronous chemotherapy and radiotherapy be given safely without significant enhancement of acute or late toxicity, without compromising on dose intensity of either modality and without adversely affecting quality of life or cosmesis? |
| Ethics approval(s) | West Midlands Research Ethics Committee, 09/04/1998, MREC/98/7/16 |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Two arms: Arm 1 - Synchronous treatment (Chemotherapy - Radiotherapy - Chemotherapy) Arm 2 - Sequential treatment (Chemotherapy - Radiotherapy) |
| Intervention type | Other |
| Primary outcome measure(s) |
Local tumour recurrence rates at 5 and 10 years |
| Key secondary outcome measure(s) |
1. Distant and overall recurrence rates |
| Completion date | 25/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 2298 |
| Key inclusion criteria | 1. Histological diagnosis of invasive breast carcinoma (unilateral if participating in the Cosmesis Study) 2. Wide local excision or mastectomy with macroscopic complete excision of clinically early stage disease and no evidence of metastases 3. There is a clear indication for both adjuvant chemotherapy and radiotherapy, or the patient has been randomised to these treatments in another study 4. The intended schedules can be given synchronously and the patient is considered suitable to receive either treatment sequence 5. Medically fit enough to complete chemotherapy and radiotherapy, with adequate cardiac, renal, hepatic and bone marrow function 6. The patient has given written informed consent 7. No prior chemotherapy (other than hormone manipulation) 8. No prior malignancy (except skin basal/squamous cell or in situ carcinoma) 9. Not currently pregnant or lactating, no intention of pregnancy during treatment 10. No other medical or social contra-indication to entry and follow-up |
| Key exclusion criteria | N/A |
| Date of first enrolment | 02/07/1998 |
| Date of final enrolment | 25/03/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
CRUK Clinical Trials Unit
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2006 | 25/01/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
Editorial Notes
25/01/2019: Publication reference added
17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
09/06/2017: No publications found in PubMed, verifying study status with principal investigator.
