Contact information
Type
Scientific
Primary contact
Dr Sarah Bowden
ORCID ID
Contact details
CRUK Clinical Trials Unit
Institute for Cancer Studies
The University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 4371
BTT@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003893
Protocol/serial number
BR3015
Study information
Scientific title
Sequencing of Chemotherapy and Radiotherapy in Adjuvant Breast cancer
Acronym
SECRAB
Study hypothesis
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
West Midlands Research Ethics Committee, 09/04/1998, MREC/98/7/16
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
Two arms:
Arm 1 - Synchronous treatment (Chemotherapy - Radiotherapy - Chemotherapy)
Arm 2 - Sequential treatment (Chemotherapy - Radiotherapy)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Local tumour recurrence rates at 5 and 10 years
Secondary outcome measures
1. 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 trial start date
02/07/1998
Overall trial end date
25/03/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
2298
Participant exclusion criteria
N/A
Recruitment start date
02/07/1998
Recruitment end date
25/03/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
CRUK Clinical Trials Unit
Birmingham
B15 2TT
United Kingdom
Funders
Funder type
Charity
Funder name
Cancer Research UK (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