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

DCIS Clinical Trial

— DUCHESS  

Official title:

Evaluation of the Ductal Carcinoma In Situ Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766881
• Other study ID #: OCOG-2016-DUCHESS
• Status: Completed
• Start date: August 2016
• Est. completion date: September 30, 2019

Study information

• Verified date: August 2019
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: September 30, 2019
• Est. primary completion date: June 13, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 46 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma in Situ
• DCIS

Locations

Country	Name	City	State
Canada	Royal Victoria Regional Health Centre	Barrie	Ontario
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Cancer Centre of Southeastern Ontario at Kingston	Kingston	Ontario
Canada	London Regional Cancer Centre	London	Ontario
Canada	Credit Valley Hospital	Mississauga	Ontario
Canada	Ottawa Regional Cancer Centre	Ottawa	Ontario
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Sunnybrook Odette Cancer Centre	Toronto	Ontario
Canada	BC Cancer Agency - Vancouver Island	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   OCOG website accessed by clinical centres