Condition category
Cancer
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
05/06/2014
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 John Yarnold

ORCID ID

Contact details

The Royal Marsden NHS Trust
Downs Road
Sutton
SM2 5PT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

REC00049

Study information

Scientific title

Acronym

Study hypothesis

Post-operative radiotherapy in women with early breast cancer accounts for more than 25% of NHS radiotherapy resource usage. Improvements in treatment accuracy for this important group of patients have lagged far behind technological developments applied routinely in patients with cancer at other anatomical sites. This has been a major contribution to unacceptably high rates of complications in some radiotherapy departments. The current proposal aims to test the clinical benefits of improved radiation dose distributions in the breast and ribcage of women prescribed radiotherapy after breast-preserving surgery for early stage cancer. The hypothesis is that these improvements will halve the risk of adverse events and improve functional status. Simple procedures for designing and manufacturing 3D breast tissue compensators will be tested against standard techniques in a randomised clinical trial. The benefits of reduced radiation morbidity using a combination of external assessments and patient self-assessments. The aim of this study is to test the clinical benefits of improved radiation dose distributions in the breast and ribcage of women prescribed radiotherapy after breast-preserving surgery for early stage cancer.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast cancer

Intervention

3D breast tissue compensators will be tested against standard techniques.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/1996

Overall trial end date

01/12/1998

Reason abandoned

Eligibility

Participant inclusion criteria

Women with early breast cancer, histological confirmation of invasive carcinoma, breast-preserving surgery, brassiere cup size C or more, no previous malignancy.

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/1996

Recruitment end date

01/12/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Royal Marsden NHS Trust
Sutton
SM2 5PT
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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