Evaluation of the DCIS Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS
DUCHESS
Evaluation of the Ductal Carcinoma In Situ Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS
1 other identifier
observational
281
1 country
12
Brief Summary
To evaluate whether the use of the Oncotype DX DCIS score can guide delivery of radiation in women with low to moderate risk DCIS who have had breast conserving surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2016
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2016
CompletedFirst Posted
Study publicly available on registry
May 10, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedFebruary 19, 2020
August 1, 2019
2.9 years
May 6, 2016
February 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in radiotherapy treatment recommendation made by physician
The primary outcome is change in treatment recommendation by the radiation oncologist. Physicians will be asked to indicate their preliminary treatment recommendation at the first visit based on clinical factors alone. They will be asked to describe course of radiation including dose and number of fractions. They will then be asked to make a final treatment recommendation when the DCIS score is available. If the physician final recommendation is not consistent with the DCIS score predicted treatment, they will be asked to indicate reasons for their recommendation. If radiation is recommended, they will be asked to indicate the treatment prescription including dose and number of fractions. The actual treatment received by the patient will also be collected.
2.5 years
Secondary Outcomes (1)
Change in radiotherapy treatment preference by patient
2.5 years
Study Arms (1)
Patients with DCIS
Whether patients with DCIS receive radiotherapy based on Oncotype DX DCIS score, radiation oncologist treatment recommendation and patient's decision.
Eligibility Criteria
Prospective cohort study conducted in Ontario in women with a low to moderate risk DCIS following breast conserving surgery who are candidates for radiation. Eligibility status should be confirmed by the referring physician or delegate prior to enrollment. It is important that no exceptions are made to the eligibility criteria. Questions related to eligibility requirements and/or specific criteria should be addressed with OCOG prior to enrollment
You may qualify if:
- (1) Women with newly diagnosed breast cancer treated by definitive surgery with histological evidence limited to DCIS.
You may not qualify if:
- Age \< or = 45;
- Treated by mastectomy;
- Surgical margins of \<1mm;(re-excisions may be performed where results are regarded as clear margins, these cases will not exclude patients);
- Tumour size \>2.5cm;
- Any invasive breast cancer including micro invasion;
- Histological evidence of multifocality (defined as having more than one distinct focus of DCIS with \>5mm of intervening benign breast tissue in one quadrant of the breast);
- Any associated lobular carcinoma in situ;
- Previous diagnosis of ipsilateral invasive carcinoma or DCIS of the breast;
- Any contraindication for whole breast irradiation such as chronic heart or lung disease or previous ipsilateral chest wall radiotherapy;
- Physician/patient unwilling to comply with study protocol; and
- Inability to provide informed consent (e.g. dementia or severe cognitive impairment).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2, Canada
BC Cancer Agency - Vancouver Island
Victoria, British Columbia, V8R6V5, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, K7L 5P9, Canada
London Regional Cancer Centre
London, Ontario, N6A4L6, Canada
Credit Valley Hospital
Mississauga, Ontario, L5M2N1, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Related Links
Biospecimen
patient's tumour sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eileen Rakovitch, M.D.
Sunnybrook Health Sciences Odette Cancer Centre
- PRINCIPAL INVESTIGATOR
Tim Whelan, M.D.
Juravinski Cancer Centre
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2016
First Posted
May 10, 2016
Study Start
August 1, 2016
Primary Completion
June 13, 2019
Study Completion
September 30, 2019
Last Updated
February 19, 2020
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
Genomic Health will provide results to referring physician, OCOG will have access to results