Surgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma
A Randomized Phase II Study Comparing Surgical Excision Versus Neoadjuvant Radiotherapy Followed by Delayed Surgical Excision of Ductal Carcinoma In Situ (NORDIS)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This small study compares surgery alone with radiation before a later surgery for ductal carcinoma in situ (DCIS), cancer cells that stay inside the breast’s milk ducts. It is for women age 18 or older with DCIS found on breast scans but not felt as a lump. Researchers will compare findings from the tissue removed during surgery.
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)
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women age 18 or older who sign a written consent form.
- A needle biopsy must show DCIS in a breast area found on a scan but not felt as a lump. The biopsy must be within 16 weeks before assignment to a study group.
- The abnormal area on a mammogram or MRI must measure 4 cm or less, even if there is more than one spot.
- A marker must be placed at the biopsy site and confirmed on a scan.
- Plan to have a lumpectomy, surgery to remove the abnormal area. Removal of the whole breast is allowed later if needed or chosen.
- A radiation doctor must confirm that treatment can target part of the breast, covering no more than 30% of it.
- Must be able to do all or most self-care and be out of bed or a chair for more than half of waking hours.
- DCIS may have different hormone receptor and HER2 test results. Past cancer in the other breast and certain other abnormal breast cells are allowed.
Who can't join
- Cancer that has grown outside the milk ducts, even a tiny amount; cancer in underarm lymph nodes; or Paget’s disease, a cancer involving the nipple.
- DCIS spanning more than 4 cm, a mass seen on a scan or felt as a lump, or no abnormal area left on scans after biopsy.
- Past cancer in the same breast, or current cancer in the other breast.
- Pregnant or breastfeeding.
- Past radiation to the same breast or side of the chest, or not eligible for radiation to only part of the breast.
- Active collagen vascular disease, an illness that affects the body’s connective tissues.
- A mental health condition, addiction, or another condition that the study doctor believes would prevent study participation or affect the results.
- Hormone-blocking treatment between study group assignment and surgery, unless continuing it for cancer in the other breast.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (1)
CA
- Stanford University · Stanford, CA 94304Vishal Joshi · Study contact · 650-725-7489 · vishalj4@stanford.eduIrene Wapnir, MD · Principal investigatorMore trials in Stanford