A Randomized Phase II Study Comparing Surgical Excision Versus Neoadjuvant Radiotherapy Followed by Delayed Surgical Excision of Ductal Carcinoma In Situ (NORDIS)
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)
Detailed 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.
Arms & 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)
Outcome measures
Primary
Rate of ductal carcinoma in situ (DCIS) pathologic complete response
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.
Time frame: 12 weeks
Secondary
Correlation of ductal carcinoma in situ (DCIS) subtypes with rate of DCIS pathologic complete response to neoadjuvant partial breast irradiation (PBI)
Time frame: 12 weeks
Tumor grade comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
Time frame: 12 weeks
Nuclear atypia comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
Time frame: 12 weeks
Percent tumor necrosis comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
Time frame: 12 weeks
Tumor cellularity comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
Time frame: 12 weeks
Proportion of subjects experiencing a wound complication on Arm 1 compared to Arm 2
Time frame: 12 weeks
Correlation of post-radiation imaging characteristics with pathologic findings
Time frame: 12 weeks
Rate of invasive carcinoma comparison in Arm 1 to Arm 2
Time frame: 12 weeks
Eligibility criteria
Study locations (1)
Stanford University
Stanford, California, 94304