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
Protocol serial number	REC00049
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive London (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/12/1998

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
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

United Kingdom
England

Study participating centre

The Royal Marsden NHS Trust

Sutton
SM2 5PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.