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
-
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REC00049
Study information
Scientific title
Radiation dosimetry in determining complications and quality of life in women treated for breast-preserving surgery and radiotherapy
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 measure
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 (if study stopped)
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
Total final enrolment
240
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
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
Basic results (scientific)
Publication list
2007 results in: https://www.ncbi.nlm.nih.gov/pubmed/17224195 (added 31/10/2019)