Radiation dosimetry in determining complications and quality of life in women treated for breast-preserving surgery and radiotherapy

ISRCTN	ISRCTN92388887
DOI	https://doi.org/10.1186/ISRCTN92388887
Secondary identifying numbers	REC00049

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 31/10/2019

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 John Yarnold
Scientific

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

Email	abc@email.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Radiation dosimetry in determining complications and quality of life in women treated for breast-preserving surgery and radiotherapy
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Breast cancer
Intervention	3D breast tissue compensators will be tested against standard techniques.
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/12/1996
Completion date	01/12/1998

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target number of participants	Not provided at time of registration
Total final enrolment	240
Key inclusion criteria	Women with early breast cancer, histological confirmation of invasive carcinoma, breast-preserving surgery, brassiere cup size C or more, no previous malignancy.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/12/1996
Date of final enrolment	01/12/1998

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The Royal Marsden NHS Trust

Sutton
SM2 5PT
United Kingdom

Sponsor information

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive London (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2007	31/10/2019	Yes	No

Editorial Notes

31/10/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.