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

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

Study Overview

• Status: Completed
• Conditions: DCIS

Detailed Description

A prospective cohort study, conducted in Canada, to evaluate whether the use of the DCIS score changes the treatment recommended and the treatment received in women with low to moderate risk DCIS following breast conserving surgery who are candidates for radiation therapy. We plan to study 280 eligible, consenting women who will have their tumour tissue specimen sent to Genomic Health to assess their DCIS score.

At each centre, all patients with DCIS referred to radiation oncology will be documented. When a physician identifies an eligible patient, the patient will be approached by the referring physician or delegate to voluntarily provide informed consent to participate in this study. Consenting patients will be registered through the Ontario Clinical Oncology Group's (OCOG) web-based registration system. Data related to the patient demographics, surgery details, and tumour characteristics will be collected. The preliminary treatment recommendation and patient preference for treatment will be documented. Patient Decisional Conflict will be documented by the patient using the Decisional Conflict Scale (DCS). The patient's tumour specimen will be sent for analysis to Genomic Health. DCIS score results will be sent to the referring physician. OCOG will also receive the DCIS score results. The final treatment recommendation, patient preference, and treatment received by the patient will be documented. Patient decisional conflict will be documented by the patient using the DCS. The study data will be verified by source documentation.

• Study Type: Observational
• Enrollment (Actual): 281

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre
    • Edmonton, Alberta, Canada, T6G1Z2
      • Cross Cancer Institute
  • British Columbia
    • Victoria, British Columbia, Canada, V8R6V5
      • BC Cancer Agency - Vancouver Island
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Royal Victoria Regional Health Centre
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre
    • Kingston, Ontario, Canada, K7L 5P9
      • Cancer Centre of Southeastern Ontario at Kingston
    • London, Ontario, Canada, N6A4L6
      • London Regional Cancer Centre
    • Mississauga, Ontario, Canada, L5M2N1
      • Credit Valley Hospital
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Regional Cancer Centre
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Thunder Bay Regional Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Odette Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

(1) Women with newly diagnosed breast cancer treated by definitive surgery with histological evidence limited to DCIS.

Exclusion Criteria:

1. Age < or = 45;
2. Treated by mastectomy;
3. Surgical margins of <1mm;(re-excisions may be performed where results are regarded as clear margins, these cases will not exclude patients);
4. Tumour size >2.5cm;
5. Any invasive breast cancer including micro invasion;
6. 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);
7. Any associated lobular carcinoma in situ;
8. Previous diagnosis of ipsilateral invasive carcinoma or DCIS of the breast;
9. Any contraindication for whole breast irradiation such as chronic heart or lung disease or previous ipsilateral chest wall radiotherapy;
10. Physician/patient unwilling to comply with study protocol; and
11. Inability to provide informed consent (e.g. dementia or severe cognitive impairment).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with DCIS; Whether patients with DCIS receive radiotherapy based on Oncotype DX DCIS score, radiation oncologist treatment recommendation and patient's decision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in radiotherapy treatment preference by patient	Secondary outcomes will include change in treatment preference by the patient for radiotherapy and change in recommendations by the physician for hormonal therapy or further surgery. It will also compare physician's prediction of LR with or without radiation that is estimated by the DCIS score. Finally, change in level of patient decisional conflict as measured by DCS will also be collected. The DCS was developed and used to evaluate the effect of decision aids on decision making by health consumers.The assumption was that decision aids would reduce the uncertainty and confusion in choosing a course of action. Decisional conflict is a state of uncertainty about the course of action to take.	2.5 years

Collaborators and Investigators

• Sponsor: Ontario Clinical Oncology Group (OCOG)
• Investigators: Principal Investigator: Eileen Rakovitch, M.D., Sunnybrook Health Sciences Odette Cancer Centre; Principal Investigator: Tim Whelan, M.D., Juravinski Cancer Centre

Publications and helpful links

Helpful Links

• OCOG website accessed by clinical centres

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): June 13, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: May 6, 2016
• First Posted (ESTIMATE): May 10, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Breast Conserving Surgery; Ductal Carcinoma in Situ; DSC
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma in Situ
• Other Study ID Numbers: OCOG-2016-DUCHESS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Genomic Health will provide results to referring physician, OCOG will have access to results