Sequencing of Chemotherapy and Radiotherapy in Adjuvant Breast cancer

ISRCTN ISRCTN84214355
DOI https://doi.org/10.1186/ISRCTN84214355
ClinicalTrials.gov number NCT00003893
Secondary identifying numbers BR3015
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

CRUK Clinical Trials Unit
Institute for Cancer Studies
The University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone +44 (0)121 414 4371
Email BTT@bham.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleSequencing of Chemotherapy and Radiotherapy in Adjuvant Breast cancer
Study acronymSECRAB
Study objectivesTo 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) studiedBreast cancer
InterventionTwo arms:
Arm 1 - Synchronous treatment (Chemotherapy - Radiotherapy - Chemotherapy)
Arm 2 - Sequential treatment (Chemotherapy - Radiotherapy)
Intervention typeOther
Primary outcome measureLocal tumour recurrence rates at 5 and 10 years
Secondary outcome measures1. Distant and overall recurrence rates
2. Survival at 5, 10 and 15 years
3. Acute toxicity causing significant treatment delay or dose reduction
4. Other late effects of treatment
Overall study start date02/07/1998
Completion date25/03/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants2298
Key inclusion criteria1. 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 criteriaN/A
Date of first enrolment02/07/1998
Date of final enrolment25/03/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

CRUK Clinical Trials Unit
Birmingham
B15 2TT
United Kingdom

Sponsor information

University Hospitals Birmingham NHS Foundation Trust (UK)
Hospital/treatment centre

Research & Development
Nuffield House
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
England
United Kingdom

ROR logo "ROR" https://ror.org/014ja3n03

Funders

Funder type

Charity

Cancer Research UK (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Plain English results No Yes
Results article results 01/04/2006 25/01/2019 Yes No

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.