NCT03909282 · Stanford University
Surgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma
(NORDIS)
What this study is about
The purpose of this pilot study is to compare by pathological findings surgical excision versus neoadjuvant radiotherapy followed by delayed surgical excision of ductal carcinoma in situ (DCIS)
View original scientific description
The purpose of this pilot study is to compare by pathological findings surgical excision versus neoadjuvant radiotherapy followed by delayed surgical excision of ductal carcinoma in situ (DCIS)
Interventions
PROCEDURE
Lumpectomy
Standard of Care surgery for DCIS (either lumpectomy or mastectomy)
RADIATION
Partial breast irradiation prior to surgery
Partial breast irradiation (PBI) will be delivered once aday for 5 days. The planned daily dose is 6 Gy prior to surgery (neo adjuvant)
Primary outcome measures
Rate of ductal carcinoma in situ (DCIS) pathologic complete response
Time frame: 12 weeks
A DCIS pathologic complete response will be defined as the absence of in situ carcinoma in the surgical resection specimen. The rate of DCIS pathologic complete response (pCR) will be calculated for Arm 1 and Arm 2.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Stanford, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 12, 2026 · Source of record for eligibility and locations