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Oncotype DX DCIS: Impact on Radiotherapy Decision Making (ONCOTYPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06046664
Recruitment Status : Active, not recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Study Description
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Brief Summary:
Prospective single centre study of patients with DCIS that have undergone breast conservation surgery.

Condition or disease Intervention/treatment Phase
Breast Cancer Diagnostic Test: ONCOTYPE DX DCIS test Not Applicable

Detailed Description:
This is a single centre (Royal Marsden Hospital - Chelsea and Sutton) non-randomised trial investigating whether the Oncotype DX DCIS score changes the radiotherapy recommendation made by clinical oncologists in patients with low to moderate risk DCIS following breast conserving surgery.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Study Assessing the Impact of the Oncotype DX DCIS Score on Radiotherapy Decision Making in the United Kingdom
Actual Study Start Date : July 7, 2020
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : December 31, 2023

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Arms and Interventions
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Arm Intervention/treatment
DCIS Test Diagnostic Test: ONCOTYPE DX DCIS test

The Oncotype DX DCIS score, comprised of 12 of the 21 genes of the Oncotype DX Recurrence score, has been developed by Genomic Health Inc.

Two clinical utility studies have now been performed in USA, assessing the value of the Oncotype DX DCIS to clinical decision making (18,19) The first study by Alvarado et al. evaluated the influence of the test in 10 centres and in 115 patients (18). The DCIS score led to a change in the treatment recommendation in 36 patients (31.3%; 26 patients had a change to no radiation and 10 patients had a change to recommend radiation). The second study similarly showed change in recommendations following the Oncotype DX DCIS test in 26.4% of cases. It is unclear what the impact of the DCIS score test would be in the UK.


Outcome Measures
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Primary Outcome Measures :
  1. Change in radiotherapy recommendation by clinician [ Time Frame: end of trial (2 years) ]
    Percentage of clinical oncology recommendations regarding radiotherapy that change pre- and post- Oncotype DX DCIS.


Secondary Outcome Measures :
  1. Determine whether the Oncotype DX DCIS score results in a change in patient decision for adjuvant radiotherapy. [ Time Frame: end of trial (2 years) ]
    Percentage of patients who change their decision regarding radiotherapy pre- and post- Oncotype DX DCIS.

  2. Determine whether the local recurrence risk estimated by clinical oncologists agrees with the local recurrence risk calculated by the Oncotype DX DCIS score (for all recurrences and for invasive recurrences only). [ Time Frame: end of trial (2 years) ]
    Agreement between the local recurrence risk estimated by clinical oncologists and the local recurrence risk calculated by the Oncotype DX DCIS score (for all recurrences and for invasive recurrences only).

  3. Determine change in patient decisional conflict pre and post Oncotype DX DCIS. [ Time Frame: end of trial (2 years) ]
    Change in patient decisional conflict scale (DCS) scores pre and post Oncotype DX DCIS

  4. Determine change in patient anxiety pre and post Oncotype DX DCIS. [ Time Frame: end of trial (2 years) ]
    Change in state anxiety and trait anxiety scores using the State Trait Anxiety Inventory (STAI) pre and post ONCOTYPE DX DCIS test

  5. Determine patient, tumour and clinician factors that are associated with clinicians changing their decision regarding radiotherapy. [ Time Frame: end of trial (2 years) ]
    Patient, tumour and clinician factors (data collected during Visit 1) that are associated with clinicians changing their decision regarding radiotherapy.

  6. Determine patient, tumour and clinician related factors that are associated with patients changing their decision regarding radiotherapy. [ Time Frame: end of trial (2 years) ]
    Patient, tumour and clinician related factors (data collected during Visit 1) that are associated with patients changing their decision regarding radiotherapy.

  7. Determine patient, tumour and clinician related factors that are associated with patients' final decision to have radiotherapy. [ Time Frame: end of trial (2 years) ]
    Patient, tumour and clinician factors that are associated with patients' final decision to have radiotherapy.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed diagnosis of DCIS
  2. DCIS treated with breast conserving surgery

Exclusion Criteria:

  1. Prior treatment for DCIS or invasive breast cancer in ipsilateral breast.
  2. Patients with contra-indications to radiotherapy, including prior breast radiotherapy
  3. Patients who undergo mastectomy for DCIS
  4. Age < 45 years old
  5. Patients with > 25mm DCIS
  6. Patients with multifocal DCIS (defined as more than 1 distinct focus of DCIS with at least 50mm of intervening benign tissue)
  7. Patients with invasive (including microinvasion) disease
  8. Patients with positive axillary nodal disease (including isolated tumour cells)
  9. Patients with close (<1mm) or positive radial margins (unless maximally surgically excised or no further DCIS on re-excision)
  10. Patients recommended adjuvant endocrine therapy
Contacts and Locations
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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): NCT06046664


Locations
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United Kingdom
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
More Information
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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT06046664    
Other Study ID Numbers: CCR4963
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No