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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN99513870
Enrollment
1000
Registered
2001-07-01
Start date
1990-05-09
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Cancer Breast Cancer

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

Sponsors

Cancer Research UK (CRUK) (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Involved excision margins 2. Paget's Disease 3. Nodal spread

Design outcomes

Primary

MeasureTime frame
1. Local control of disease 2. Any involvement of contralateral breast 3. Overall survival and cause-specific mortality

Secondary

MeasureTime frame
Not provided at time of registration

Countries

Australia, New Zealand, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026