Clinical trial · Observational
Evaluation of the DCIS Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS
Evaluation of the Ductal Carcinoma In Situ Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS
NCT02766881CI-TRIAL-00043501DUCHESScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DCIS | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients with DCIS
- description
- Whether patients with DCIS receive radiotherapy based on Oncotype DX DCIS score, radiation oncologist treatment recommendation and patient's decision.
Primary outcomes (1)
- measure
- Change in radiotherapy treatment recommendation made by physician
- timeFrame
- 2.5 years
- description
- 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 outcomes (1)
- measure
- Change in radiotherapy treatment preference by patient
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 46 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.