Surgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT03909282
Status
Recruiting
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Conditions

  • Ductal Breast Carcinoma in Situ

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lumpectomy — PROCEDURE
    Standard of Care surgery for DCIS (either lumpectomy or mastectomy)
  • Partial breast irradiation prior to surgery — RADIATION
    Partial breast irradiation (PBI) will be delivered once aday for 5 days. The planned daily dose is 6 Gy prior to surgery (neo adjuvant)

Study Details

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)

Key Dates

Start date
Mar 22, 2019
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Surgical Excision
    Surgical excision of ductal carcinoma
  • Experimental: Neoadjuvant partial breast irradiation
    Partial breast irradiation will be delivered once a day for 5 days before surgery. The planned daily dose is 6 Gy.

Primary Outcome Measure

Rate of ductal carcinoma in situ (DCIS) pathologic complete response [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94304
Sinyoung Park
[email protected]
650-721-4485
Irene Wapnir, MD (PRINCIPAL_INVESTIGATOR)

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