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

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ClinicalTrials.gov Identifier: NCT02766881
Recruitment Status : Recruiting
First Posted : May 10, 2016
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

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 Type : Observational
Estimated Enrollment : 280 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
Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

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.



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


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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766881


Contacts
Contact: Luciana Spadafora 905-527-2299 ext 42655 spadafl@mcmaster.ca
Contact: Sharon Nason 905-527-2299 ext 42622 nasons@mcmaster.ca

Locations
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Jeffrey Cao, M.D.    403-521-3077    jeffrey.Cao@albertahealthservices.ca   
Contact: Eva Gyonyor    403-521-3077    eva.gyonyor@albertahealthservices.ca   
Principal Investigator: Jeffrey Cao, M.D.         
Sub-Investigator: Ivo Olivotto, M.D.         
Sub-Investigator: Petra Grendarova, M.D.         
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G1Z2
Contact: Ericka Wiebe, M.D.    780-432-8755    ericka.wiebe@ahs.ca   
Contact: Holly Toker    780-577-8105    holly.toker@ahs.ca   
Principal Investigator: Ericka Wiebe, M.D.         
Sub-Investigator: Susan Chafe, M.D.         
Sub-Investigator: Julie Cuartero, M.D.         
Sub-Investigator: Brita Danielson, M.D.         
Sub-Investigator: Zsolt Gabos, M.D.         
Sub-Investigator: Fleur Huang, M.D.         
Sub-Investigator: Kurian Jospeh, M.D.         
Sub-Investigator: Keith Tankel, M.D.         
Sub-Investigator: Barbara krause, M.D.         
Canada, British Columbia
BC Cancer Agency - Vancouver Island Recruiting
Victoria, British Columbia, Canada, V8R6V5
Contact: Sally Smith, M.D.    250-519-5576    ssmith11@bccancer.bc.ca   
Contact: Senz Hamilton, R.N.    250-519-5741    senz.hamilton@bccancer.bc.ca   
Principal Investigator: Sally Smith, M.D.         
Sub-Investigator: Tanya Berrang, M.D.         
Sub-Investigator: Pauline Truong, M.D.         
Canada, Ontario
Royal Victoria Regional Health Centre Recruiting
Barrie, Ontario, Canada, L4M 6M2
Contact: Christiaan Stevens, M.D.    705-728-9090    stevensc@rvh.on.ca   
Contact: Christine DiMarco    705-728-9090 ext 43586    dimarcoc@rvh.on.ca   
Principal Investigator: Christiaan Stevens, M.D.         
Sub-Investigator: Matthew Follwell, M.D.         
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Iwa Kong, M.D.    905-387-9711 ext 64704    kongi@hhsc.ca   
Contact: Sheila Mitchell    905-387-9711 ext 64425    mitchellsh@hhsc.ca   
Cancer Centre of Southeastern Ontario at Kingston Recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: Conrad Falkson    613-519-6666 ext 4509    conrad.falkson@krcc.on.ca   
Contact: Carrie Lindsay    613-519-6666 ext 6654    conrad.falkson@krcc.on.ca   
Principal Investigator: Conrad Falkson, M.D.         
London Regional Cancer Centre Recruiting
London, Ontario, Canada, N6A4L6
Contact: Francisco Perera, M.D.    519-685-8650    francisco.perera@lhsc.on.ca   
Contact: Lorraine Hewett    519-685-8618    Lorraine.Hewett@lhsc.on.ca   
Principal Investigator: Francisco Perera, M.D.         
Sub-Investigator: Jeffrey Cao, M.D.         
Sub-Investigator: Michael Lock, M.D.         
Sub-Investigator: Nancy Read, M.D.         
Sub-Investigator: Tracy Sexton, M.D.         
Sub-Investigator: Brian Yaremko, M.D.         
Sub-Investigator: Edward Yu, M.D.         
Queensway Health Centre Withdrawn
Mississauga, Ontario, Canada, L5M 2N1
Credit Valley Hospital Recruiting
Mississauga, Ontario, Canada, L5M2N1
Contact: Senti Senthelal, M.D.    905-813-1100 ext 5115    senti.senthelal@thp.ca   
Contact: Helena Wong    905-813-1100 ext 4759    helena.wong@thp.ca   
Principal Investigator: Senti Senthelal, M.D.         
Sub-Investigator: Marisa Finlay, M.D.         
Sub-Investigator: Jidong Lian, M.D.         
Sub-Investigator: John Radwan, M.D.         
Sub-Investigator: Sarah Rauth, M.D.         
Sub-Investigator: Johnathan Tsao, M.D.         
Sub-Investigator: Jonathan Wan, M.D.         
Sub-Investigator: Yongjin Wang, M.D.         
Sub-Investigator: Jasper Yuen, M.D.         
Ottawa Regional Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Laval Grimard, M.D.    613-737-7700 ext 70196    lgrimard@ottawahospital.on.ca   
Contact: Diane Lister    613-737-7700 ext 70305    dilister@toh.ca   
Principal Investigator: Laval Grimard, M.D.         
Sub-Investigator: Caudrelier Jean-Michel, M.D.         
Sub-Investigator: Peter Cross, M.D.         
Sub-Investigator: Samy El-Sayed, M.D.         
Sub-Investigator: Catherine Lochrin, M.D.         
Sub-Investigator: Krystine Lupe, M.D.         
Sub-Investigator: Joanne Meng, M.D.         
Sub-Investigator: Scott Morgan, M.D.         
Northeastern Cancer Centre;Health Sciences North Withdrawn
Sudbury, Ontario, Canada, P3E 5J1
Thunder Bay Regional Health Sciences Centre Recruiting
Thunder Bay, Ontario, Canada, P7B 6V4
Contact: Margaret Anthes, M.D.    807-684-7566    anthesm@tbh.net   
Contact: Lori Moon    807-684-7226    moonl@tbh.net   
Principal Investigator: Margaret Anthes, M.D.         
Sub-Investigator: Adrien Chan, M.D.         
Sunnybrook Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Eileen Rakovitch, M.D.    416-480-4974    eileen.rakovitch@sunnybrook.ca   
Principal Investigator: Eileen Rakovitch, M.D.         
Sub-Investigator: Ida Ackerman, M.D.         
Sub-Investigator: Gregory Czarnota, M.D.         
Sub-Investigator: Mary Doherty, M.D.         
Sub-Investigator: Irene Karam, M.D.         
Sub-Investigator: Justin Lee, M.D.         
Sub-Investigator: Eric Leung, M.D.         
Sub-Investigator: Hany Soliman, M.D.         
Sub-Investigator: Ewa Szumacher, M.D.         
Sub-Investigator: Danny Vespirini, M.D.         
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Anne Koch, M.D.    416-946-2125    anne.koch@rmp.uhn.ca   
Contact: Daniel Ang    416-946-4501 ext 5573    daniel.ang@uhn.ca   
Principal Investigator: Anne Koch, M.D.         
Sub-Investigator: Anthony Fyles, M.D.         
Sub-Investigator: Fei-Fei Liu, M.D.         
Sub-Investigator: Jennifer Croke, M.D.         
Sub-Investigator: Tatiana Conrad, M.D.         
Sub-Investigator: Wilfred Levin, M.D.         
Sub-Investigator: Kathy Han, M.D.         
Sub-Investigator: Aisling Barry, M.D.         
Sub-Investigator: Joelle Helou, M.D.         
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

Additional Information:
Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT02766881     History of Changes
Other Study ID Numbers: OCOG-2016-DUCHESS
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: June 2018
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, Intraductal, Noninfiltrating
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Breast Carcinoma In Situ
Neoplasms, Ductal, Lobular, and Medullary