Evaluation of the DCIS Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS (DUCHESS)

• ClinicalTrials.gov Identifier: NCT02766881
• Recruitment Status: Completed
• First Posted: May 10, 2016
• Last Update Posted: February 19, 2020
• Sponsor: Ontario Clinical Oncology Group (OCOG)
• Information provided by (Responsible Party): Ontario Clinical Oncology Group (OCOG)

Study Description

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

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 281 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of the Ductal Carcinoma In Situ Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS
• Actual Study Start Date: August 2016
• Actual Primary Completion Date: June 13, 2019
• Actual Study Completion Date: September 30, 2019

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Change in radiotherapy treatment recommendation made by physician [ Time Frame: 2.5 years ]
   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.

Secondary Outcome Measures :

1. Change in radiotherapy treatment preference by patient [ Time Frame: 2.5 years ]
   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.

Biospecimen Retention:   Samples Without DNA

patient's tumour sample

Eligibility Criteria

• Ages Eligible for Study: 46 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• 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

Criteria

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).

Contacts and Locations

Locations

Canada, Alberta

Tom Baker Cancer Centre

Calgary, Alberta, Canada, T2N 4N2

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G1Z2

Canada, British Columbia

BC Cancer Agency - Vancouver Island

Victoria, British Columbia, Canada, V8R6V5

Canada, Ontario

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada, L4M 6M2

Juravinski Cancer Centre

Hamilton, Ontario, Canada, L8V 5C2

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, Canada, K7L 5P9

London Regional Cancer Centre

London, Ontario, Canada, N6A4L6

Credit Valley Hospital

Mississauga, Ontario, Canada, L5M2N1

Ottawa Regional Cancer Centre

Ottawa, Ontario, Canada, K1H 8L6

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada, P7B 6V4

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada, M4N 3M5

Princess Margaret Hospital

Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

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

More Information

Additional Information:

OCOG website accessed by clinical centres 

• Responsible Party: Ontario Clinical Oncology Group (OCOG)
• ClinicalTrials.gov Identifier: NCT02766881
• Other Study ID Numbers: OCOG-2016-DUCHESS
• First Posted: May 10, 2016
• Last Update Posted: February 19, 2020
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Genomic Health will provide results to referring physician, OCOG will have access to results

Keywords provided by Ontario Clinical Oncology Group (OCOG):

Ductal Carcinoma in Situ; DSC; Breast Conserving Surgery

Additional relevant MeSH terms:

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms