Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer

Part of paid clinical trials in Santa Monica, California.

Sponsor
Saint John's Cancer Institute
Study ID
NCT04603209
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Intraoperative Radiation Therapy (IORT) — RADIATION
    IORT involving 50kV Xrays to a dose of 20 Gy during breast-conserving surgery

Study Details

This is a prospective, registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy (IORT) during breast-conserving surgery. The purpose of this study is to further validate the long-term effectiveness and safety of this treatment method. We aim to assess short and long-term patient outcomes associated with IORT, including perioperative complications, local and distance disease recurrences, as well as disease-free survival and overall survival.

Key Dates

Start date
Oct 3, 2018
Status verified
Apr 2024
Primary completion
Oct 3, 2028
Completion
Oct 3, 2028

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: IORT
    All participants who plan to undergo partial mastectomy for treatment of early stage breast cancer will be considered for eligibility for IORT. Patient with single breast cancer less than 3cm in disease span, clinical negative axillary node will be offered the option of having IORT. If IORT is delivered following surgical resection of the tumor they will be followed in this registry for short and long term outcomes.

Primary Outcome Measure

Disease Recurrence [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
John Wayne Cancer Institute, Providence Saint John's Health CenterSanta MonicaCalifornia90404
Janie Grumley, MD
[email protected]
310-582-7100
Robert Wollman, MD (SUB_INVESTIGATOR)
Lisa Chaiken, MD (SUB_INVESTIGATOR)

Find similar trials in Santa Monica, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
John Wayne Cancer Institute, Providence Saint John's Health Center· Santa Monica, CA

Related Studies