A Randomized Phase II Study Comparing Surgical Excision Versus Neoadjuvant Radiotherapy Followed by Delayed Surgical Excision of Ductal Carcinoma In Situ (NORDIS)
Stanford University
Summary
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)
Description
There will be measurable histopathological treatment effects identified in Arm 2 cases receiving pre-operative radiation. Results found are expected to assist in designing a more definitive study. Compare pathological findings in individuals with ductal carcinoma in situ (DCIS) who have surgical excision versus neoadjuvant radiotherapy followed by delayed surgical excision. It is noted that "phase 2" is formally associated with drug studies. Nonetheless, it is however part of the time of this study.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 mar…
Interventions
- ProcedureLumpectomy
Standard of Care surgery for DCIS (either lumpectomy or mastectomy)
- RadiationPartial 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)
Location
- Stanford UniversityStanford, California