A randomised trial of custom-made compensators versus standard wedge compensators for breast radiotherapy

ISRCTN	ISRCTN48733595
DOI	https://doi.org/10.1186/ISRCTN48733595
Secondary identifying numbers	Breast Dosimetry

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

- - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A randomised trial of custom-made compensators versus standard wedge compensators for breast radiotherapy
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Breast cancer
Intervention	1. Radiotherapy with either custom-made compensators 2. Standard wedge compensators
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	01/01/1997
Completion date	19/01/2000

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1997
Date of final enrolment	19/01/2000

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Research organisation

Cancer Research UK
Private sector organisation / Other non-profit organizations

Institute of Cancer Research
Government organisation / National government

Alternative name(s): Institute of Cancer Research - CIHR, CIHR Institute of Cancer Research, L'Institut du cancer, Institut du cancer, ICR - CIHR, ICR, IC
Location: Canada

Royal Marsden Hospital

No information available

South East Thames Regional Health Authority

No information available

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