Condition category
Cancer
Date applied
15/10/2002
Date assigned
15/10/2002
Last edited
08/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

- - -

ORCID ID

Contact details

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

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

http://www.cancer.org.uk

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)

l'Institut du cancer, 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

Publication citations

Additional files

Editorial Notes