Clinical trial NCT06046664: Oncotype DX DCIS: Impact on Radiotherapy Decision Making
Official title: A Study Assessing the Impact of the Oncotype DX DCIS Score on Radiotherapy Decision Making in the United Kingdom
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 78
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

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.

Eligibility 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

Primary outcomes:
measure: Change in radiotherapy recommendation by clinician
timeFrame: end of trial (2 years)
Secondary outcomes:
measure: Determine whether the Oncotype DX DCIS score results in a change in patient decision for adjuvant radiotherapy.
timeFrame: end of trial (2 years)
measure: 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).
timeFrame: end of trial (2 years)
measure: Determine change in patient decisional conflict pre and post Oncotype DX DCIS.
timeFrame: end of trial (2 years)
measure: Determine change in patient anxiety pre and post Oncotype DX DCIS.
timeFrame: end of trial (2 years)
measure: Determine patient, tumour and clinician factors that are associated with clinicians changing their decision regarding radiotherapy.
timeFrame: end of trial (2 years)
measure: Determine patient, tumour and clinician related factors that are associated with patients changing their decision regarding radiotherapy.
timeFrame: end of trial (2 years)
measure: Determine patient, tumour and clinician related factors that are associated with patients' final decision to have radiotherapy.
timeFrame: end of trial (2 years)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
References: