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

ISRCTN ISRCTN48733595
DOI https://doi.org/10.1186/ISRCTN48733595
Protocol serial number Breast Dosimetry
Sponsor Cancer Research UK (CRUK) (UK)
Funders Cancer Research UK, Institute of Cancer Research, Royal Marsden Hospital , South East Thames Regional Health Authority
Submission date
15/10/2002
Registration date
15/10/2002
Last edited
08/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
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

Contact information

- -
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleA randomised trial of custom-made compensators versus standard wedge compensators for breast radiotherapy
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast cancer
Intervention1. Radiotherapy with either custom-made compensators
2. Standard wedge compensators
Intervention typeOther
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date19/01/2000

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/01/1997
Date of final enrolment19/01/2000

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan