Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)
Recruiting · NCT04797299 · Observational (researchers observe without assigning treatment) · Lead sponsor: Ontario Clinical Oncology Group (OCOG)
View the official record on ClinicalTrials.gov →What this trial is about
To evaluate whether the combination of clinicopathological factors and the use of the Oncotype DX DCIS score can avoid radiation in women with low risk DCIS who have had breast conserving surgery (BCS)
Who can take part
Age range
46 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Female patient \> 45 years of age with DCIS without microinvasion.
- Tumour size ≤ 2.5cm.
- Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.\*
- \* Patients with anterior margins and posterior margins ≥1 mm are eligible. Or if the dissection was confirmed to be taken to skin and down to fascia with no DCIS present at inked margins.
- Oncotype DX DCIS score with a predicted 10-year risk of LR ≤10%.
Exclusion criteria
- Multifocal DCIS.
- History of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast.
- Synchronous or previous invasive or non-invasive breast cancer.
- Prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers.
- ECOG performance status ≥3.
- Life expectancy \<10 years.
- Geographic inaccessibility for follow-up.
Where it is running
25 locations listed.
- Arthur J.E. Child Comprehensive Cancer Centre - Calgary, Alberta, Canada
- Cross Cancer Institute - Edmonton, Alberta, Canada
- BC Cancer - Abbotsford Centre - Abbotsford British Columbia, British Columbia, Canada
- BC Cancer - Centre for the North (Prince George) - Prince George, British Columbia, Canada
- BC Cancer - Fraser Valley Centre - Surrey, British Columbia, Canada
- BC Cancer - Vancouver Centre - Vancouver, British Columbia, Canada
- BC Cancer - Victoria - Victoria, British Columbia, Canada
- CancerCare Manitoba - Winnipeg, Manitoba, Canada
- QE II HSC - Nova Scotia Cancer Centre - Halifax, Nova Scotia, Canada
- Cape Breton Cancer Centre - Sydney, Nova Scotia, Canada
- Royal Victoria Regional Health Centre - Barrie, Ontario, Canada
- Juravinski Cancer Centre - Hamilton, Ontario, Canada
- London Regional Cancer Program - London, Ontario, Canada
- Regional Cancer Care, Thunder Bay Regional Health Sciences Centre - Thunder Bay, Ontario, Canada
- Sunnybrook Health Science Centre -Odette Cancer Centre - Toronto, Ontario, Canada
- University Health Network - Princess Margaret Cancer Centre - Toronto, Ontario, Canada
- Windsor Regional Cancer Centre - Windsor, Ontario, Canada
- Hôpital Charles Le Moyne (CISSS de la Montérégie-Centre) - Greenfield Park, Quebec, Canada
- CHUM - Centre Hospitalier de L'Université de Montréal - Montreal, Quebec, Canada
- Jewish General Hospital - Montreal, Quebec, Canada
- McGill University Health Centre - Montreal, Quebec, Canada
- Centre intégré de cancérologie du CHU de Québec - Université Laval - Québec, Quebec, Canada
- Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie- Centre-du-Québec (CIUSSS MCQ) - Trois-Rivières - Trois-Rivières, Quebec, Canada
- Allan Blair Cancer Centre - Regina, Saskatchewan, Canada
- Saskatoon Cancer Centre - Saskatoon, Saskatchewan, Canada