Oncotype DX DCIS: Impact on Radiotherapy Decision Making

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: ONCOTYPE DX DCIS test

• Registration Number: NCT06046664
• Lead Sponsor: Royal Marsden NHS Foundation Trust

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.

Study Timeline

• Study Start: 2020-07-07
• Study First Submitted: 2023-01-17
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-13
• Last Update Submitted: 2023-09-13
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DCIS Test	ONCOTYPE DX DCIS test	-

Primary Outcome Measures

Name	Time	Method
Change in radiotherapy recommendation by clinician	end of trial (2 years)	Percentage of clinical oncology recommendations regarding radiotherapy that change pre- and post- Oncotype DX DCIS.

Secondary Outcome Measures

Name	Time	Method
Determine change in patient decisional conflict pre and post Oncotype DX DCIS.	end of trial (2 years)	Change in patient decisional conflict scale (DCS) scores pre and post Oncotype DX DCIS
Determine whether the Oncotype DX DCIS score results in a change in patient decision for adjuvant radiotherapy.	end of trial (2 years)	Percentage of patients who change their decision regarding radiotherapy pre- and post- Oncotype DX DCIS.
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).	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).
Determine change in patient anxiety pre and post Oncotype DX DCIS.	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
Determine patient, tumour and clinician related factors that are associated with patients changing their decision regarding radiotherapy.	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.
Determine patient, tumour and clinician related factors that are associated with patients' final decision to have radiotherapy.	end of trial (2 years)	Patient, tumour and clinician factors that are associated with patients' final decision to have radiotherapy.
Determine patient, tumour and clinician factors that are associated with clinicians changing their decision regarding radiotherapy.	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.

Trial Locations

Locations (1)

The Royal Marsden NHS Foundation Trust; 🇬🇧 London, United Kingdom