Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
03/02/2011
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

Prof J Cuzick

ORCID ID

Contact details

Wolfson Institute of Preventive Medicine
Queen Mary School of Medicine and Dentistry
University of London
London
EC1M 6BQ
United Kingdom
+44 (0) 20 7882 3504
j.cuzick@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UKCCCRDCIS

Study information

Scientific title

Acronym

Study hypothesis

1. In patients with mammographically detected DCIS to compare the effectiveness of complete local excision (CLE) alone with CLE followed by radiotherapy to the residual ipsi-lateral breast tissue and/or tamoxifen 20 mg daily for five years, in reducing the incidence of subsequent invasive carcinoma of the breast
2. To monitor contralateral disease within randomised arms of the trial

Ethics approval

Not provided at time of registration

Study design

Randomised controlled 2 x 2 factorial 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. Treatment A: Complete local excision with no further initial local or systemic therapy.
2. Treatment B: Complete local excision followed by supervoltage radiotherapy to the residual breast tissue to a dose of 50 Gy given in twenty-five fractions over five weeks. Radiotherapy to commence no later than eight weeks after the final surgical procedure.
3. Treatment C: Complete local excision followed by tamoxifen 20 mg daily for five years. Tamoxifen therapy to commence no later than eight weeks after the final surgical procedure.
4. Treatment D: Complete local excision followed by radiotherapy and tamoxifen (as above). If wished patients may be randomised for one treatment only, i.e. tamoxifen or radiotherapy, in which case the other treatment may electively be given or not given.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Local control of disease
2. Any involvement of contralateral breast
3. Overall survival and cause-specific mortality

Secondary outcome measures

Not provided at time of registration

Overall trial start date

09/05/1990

Overall trial end date

30/08/1996

Reason abandoned

Eligibility

Participant inclusion criteria

1. Unilateral or bilateral DCIS which is cosmetically suited to breast conservation, which has been detected as a result of attendance at a screening centre, which is without evidence of invasion, and which has been completely excised as determined by free margins on histological examination
2. Patients with similarly defined DCIS lesions, in whom the diagnosis of DCIS has been made as a result of mammograms taken following referral to a diagnostic clinic
3. Patients with Paget's disease of the nipple, lobular carcinoma in situ of the breast or atypical hyperplasia in the absence of DCIS are excluded
4. Pathologist must be able to state that the excision margins are clear, even after re-excision
5. No axillary lymph node involvement
6. Able to receive either treatment

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1,000

Participant exclusion criteria

1. Involved excision margins
2. Paget's Disease
3. Nodal spread

Recruitment start date

09/05/1990

Recruitment end date

30/08/1996

Locations

Countries of recruitment

Australia, New Zealand, United Kingdom

Trial participating centre

Wolfson Institute of Preventive Medicine,
London
EC1M 6BQ
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 (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21145284

Publication citations

  1. Results

    Cuzick J, Sestak I, Pinder SE, Ellis IO, Forsyth S, Bundred NJ, Forbes JF, Bishop H, Fentiman IS, George WD, Effect of tamoxifen and radiotherapy in women with locally excised ductal carcinoma in situ: long-term results from the UK/ANZ DCIS trial., Lancet Oncol., 2011, 12, 1, 21-29, doi: 10.1016/S1470-2045(10)70266-7.

Additional files

Editorial Notes