BASO DCIS II
Randomised trial testing observation (no radiotherapy) against radiotherapy in women with low-risk completely excised ER positive ductal carcinoma in situ (DCIS) of the breast on adjuvant endocrine therapy.
Disease site: Breast cancer
Treatment modality: Radiotherapy
Status: In active follow-up
Trial details
In the UK, DCIS currently comprises 20% of screen-detected cancers. It is generally agreed that adequate local treatment comprises either simple mastectomy alone or complete microscopic tumour excision and radiotherapy. Although radiotherapy has been shown to reduce the risk of recurrence, many clinicians are reluctant to use it in all patients due to the lack of evidence that it affects mortality. In the UK only 30% of patients with DCIS receive radiotherapy, whereas elsewhere in Europe and in the USA it is standard therapy.
Previous trials were not prospectively designed to identify low or high risk subgroups of DCIS patients. The purpose of this study is to identify, within a trial utilising adjuvant endocrine therapy, the group of patients who can be spared radiotherapy. The primary aims are to test the effects of withholding radiotherapy in terms of ipsilateral tumour relapse and quality of life. Secondary aims are to identify the minimum surgical margins required to minimise local recurrence rate and to identify molecular markers that predict for ipsilateral tumour recurrence. Substudies include a Quality of Life Study and Biological Marker Study.
Recruitment is due to open autumn 2004 with a target total of 2000 patients to be recruited.
Chief Investigator: Professor Nigel Bundred, University of Manchester
ICR-CTSU Scientific Lead: Professor Judith Bliss
Trial management contact: [email protected]
ISRCTN: 22614215
Sponsor: University of Manchester
Funding: Cancer Research UK (CRUK/05/005)
Publications and presentations
Mills J, A'Hern R, Bliss JM, Bundred N, Hopwood P, on behalf of the BASO-DCIS Trial Management Group. The psychological impact of the diagnosis and treatment of DCIS. Psychooncology. 2009;18(Suppl 2):S163-S64
Mills J, A'Hern R, Bliss JM, Bundred N, Hopwood P, on behalf of the BASO-DCIS Trial Management Group. The Psychological impact of the diagnosis and treatment of DCIS (BASO-DCISII CR UK 05/0005). National Cancer Research Institute (NCRI) Cancer Conference 2009; Nov 2009; Birmingham, UK. NCRI.