Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
23/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

University Hospitals Birmingham NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes