Comparing surgical excision and radiotherapy followed by surgery for ductal carcinoma in situ
A Randomized Phase II Study Comparing Surgical Excision Versus Neoadjuvant Radiotherapy Followed by Delayed Surgical Excision of Ductal Carcinoma In Situ (NORDIS)
This study is testing whether having surgery right away or getting radiation therapy first followed by surgery is better for people with ductal carcinoma in situ (DCIS).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Stanford University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT03909282 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to compare the pathological outcomes of surgical excision versus neoadjuvant radiotherapy followed by delayed surgical excision in patients with ductal carcinoma in situ (DCIS). Participants will be randomly assigned to one of the two treatment arms, with measurable histopathological effects expected in those receiving pre-operative radiation. The findings from this study are intended to inform the design of a more definitive study in the future.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with a confirmed diagnosis of ductal carcinoma in situ and specific imaging characteristics.
Not a fit: Patients with advanced breast cancer or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with ductal carcinoma in situ, potentially enhancing surgical outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in evaluating the effects of neoadjuvant therapies in breast cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Core needle biopsy demonstrating DCIS (ductal carcinoma in situ) of non-palpable, image-detected breast abnormality * Signed and dated IRB-approved written informed consent * Women 18 years of age or older * Mammographic calcifications or MRI non-mass enhancement measuring 4 cm or less in greatest dimension, including multifocal disease * Estrogen receptor positive or negative, progesterone receptor positive, negative or unknown; HER2 positive, negative or unknown DCIS is allowed * Diagnostic needle biopsy within 16 weeks of randomization * Patients must have a biopsy marker placed within the tumor bed confirmed on post biopsy imaging. * Placement of Savi scout optical reflectance marker in tumor bed area as a wireless guide for surgery and for neoRT treatment planning is preferred but not required if anatomic metallic markers are sufficient for radiation planning. Placement does not have to occur before randomization. Additionally, wire localization before surgery is permissible. * Planned lumpectomy. Mastectomy will be acceptable if lumpectomy fails by virtue of involved margins or size of lesion, or patient chooses this approach after randomization * Radiation Oncologist to ascertain feasibility of PBI prior to randomization - based on their estimation that 30% or less of the breast volume will be encompassed in the radiation fields * Patients who had a prior contralateral invasive or non-invasive (DCIS) cancer are eligible * ECOG performance status 0, 1, or 2 * Concurrent foci of atypia or lobular carcinoma in situ in the ipsilateral or contralateral breast are allowed Exclusion Criteria * Invasive carcinoma on core needle biopsy, including microinvasive carcinoma * Radiographic extent of DCIS \>4.0 cm * Mass lesion on breast imaging or palpable tumor * No residual radiographic lesion after diagnostic percutaneous core needle biopsy * Prior history of ipsilateral invasive or noninvasive breast cancer * Pregnant or breastfeeding * Prior ipsilateral breast or chest irradiation * Multicentric or multifocal DCIS, if extent is \> 4cm * Synchronous contralateral invasive or noninvasive breast cancer * Pagets' disease of the breast * Active collagen vascular disease * Positive axillary lymph nodes * Not meeting the described criteria for partial breast irradiation during initial clinical evaluation. * Psychiatric or addictive disorders or other condition, that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with the interpretation of study results * Endocrine therapy is not allowed from the time of study randomization to the completion of surgery unless the endocrine therapy is being continued for a contralateral cancer
Where this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Irene Wapnir, MD — Stanford University
- Study coordinator: Sinyoung Park
- Email: sinyoung@stanford.edu
- Phone: 650-721-4485
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.