Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Breast Dosimetry
Study information
Scientific title
A randomised trial of custom-made compensators versus standard wedge compensators for breast radiotherapy
Acronym
Study hypothesis
Not provided at time of registration
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Breast cancer
Intervention
1. Radiotherapy with either custom-made compensators
2. Standard wedge compensators
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1997
Overall trial end date
19/01/2000
Reason abandoned
Eligibility
Participant inclusion criteria
1. Early breast cancer (T1-3a N0-1 M0)
2. Histological confirmation of invasive carcinoma
3. Breast-preserving surgery
4. Higher than average risk of radiation normal tissue changes due to large breast size or irregular breast shape
5. Radiotherapy to the breast +/- lymphatics
6. No previous malignancy
7. Written informed consent
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
01/01/1997
Recruitment end date
19/01/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Research organisation
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Institute of Cancer Research
Alternative name(s)
Institut du Cancer, l'Institut du cancer, ICR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Canada
Funder name
Royal Marsden Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
South East Thames Regional Health Authority
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