| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN99513870 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | UKCCCRDCIS |
| Public title | United Kingdom randomised trial for the management of screen-detected ductal carcinoma in situ (DCIS) of the breast |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Breast Cancer |
| 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 |
| Design/methodology | Randomised controlled 2 x 2 factorial trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom, Australia, New Zealand |
| Participants - 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 |
| Participants - exclusion criteria | 1. Involved excision margins
2. Paget's Disease
3. Nodal spread |
| Patient information material |
|
| Anticipated start date | 09/05/1990 |
| Anticipated end date | 30/08/1996 |
| Status of trial | Completed |
| Target number of participants | 1000 |
| Interventions | 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. |
| Primary outcome measure(s) | 1. Local control of disease
2. Any involvement of contralateral breast
3. Overall survival and cause-specific mortality |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | 1. Cancer Research UK
2. Medical Research Council |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN99513870 |
| Date last extracted from ISRCTN register | 17/04/2008 |
