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 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 trial start date
09/05/1990
Overall trial end date
30/08/1996
Reason abandoned (if study stopped)
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
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
government organisation
Funding Body Subtype
Federal/National Government
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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21145284
Publication citations
-
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.