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 |
| Protocol serial number | UKCCCRDCIS |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funders | Cancer Research UK (UK), Medical Research Council (MRC) (UK) |
- 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
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 |
|---|---|
| j.cuzick@qmul.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled 2 x 2 factorial trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Local control of disease |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/08/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 1000 |
| 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
- United Kingdom
- England
- Australia
- New Zealand
Study participating centre
Wolfson Institute of Preventive Medicine,
London
EC1M 6BQ
United Kingdom
EC1M 6BQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2011 | Yes | No |
