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

September 13, 2023 updated by: Royal Marsden NHS Foundation Trust

A Study Assessing the Impact of the Oncotype DX DCIS Score on Radiotherapy Decision Making in the United Kingdom

Prospective single centre study of patients with DCIS that have undergone breast conservation surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
end of trial (2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
end of trial (2 years)
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).
end of trial (2 years)
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
end of trial (2 years)
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
end of trial (2 years)
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.
end of trial (2 years)
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.
end of trial (2 years)
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.
end of trial (2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2020

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CCR4963

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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