United Kingdom randomised trial for the management of screen-detected ductal carcinoma in situ (DCIS) of the breast

ISRCTN	ISRCTN99513870
DOI	https://doi.org/10.1186/ISRCTN99513870
Secondary identifying numbers	UKCCCRDCIS

Submission date: 01/07/2001
Registration date: 01/07/2001
Last edited: 03/02/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof J Cuzick
Scientific

Wolfson Institute of Preventive Medicine
Queen Mary School of Medicine and Dentistry
University of London
London
EC1M 6BQ
United Kingdom

Phone	+44 (0) 20 7882 3504
Email	j.cuzick@qmul.ac.uk

Study information

Study design	Randomised controlled 2 x 2 factorial trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	09/05/1990
Completion date	30/08/1996

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	1,000
Key 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
Key exclusion criteria	1. Involved excision margins 2. Paget's Disease 3. Nodal spread
Date of first enrolment	09/05/1990
Date of final enrolment	30/08/1996

Locations

Countries of recruitment

Australia
England
New Zealand
United Kingdom

Study participating centre

Wolfson Institute of Preventive Medicine,

London
EC1M 6BQ
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

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

Phone	+44 (0)207 317 5186
Email	kate.law@cancer.org.uk
Website	http://www.cancer.org.uk
"ROR"	https://ror.org/054225q67

Funders

Funder type

Research organisation

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

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2011		Yes	No