Recruiting

IORT

Sponsor:

Saint John's Cancer Institute

Code:

NCT04603209

Conditions

Early-stage Breast Cancer

Breast Carcinoma in Situ

Breast Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intraoperative Radiation Therapy (IORT)

Study Details

Brief summary:

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.

Conditions

Early-stage Breast Cancer

Breast Carcinoma in Situ

Breast Neoplasms

Study ID

NCT04603209

Start date

Oct 3, 2018

Status verified date

Apr, 2024

Completion date

Oct 3, 2028

Anticipated

Primary completion date

Oct 3, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification)
  • Unifocal Disease
  • Candidate for breast-conserving surgery
  • Recommended treatment by multidisciplinary team

Exclusion Criteria:

  • Clinical stage T3-4, N1-3, M1
  • Multifocal disease

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Intraoperative Radiation Therapy (IORT)

IORT involving 50kV Xrays to a dose of 20 Gy during breast-conserving surgery

Primary outcome measure

  • Disease Recurrence [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Janie Grumley, MD

(310) 582-7100janie.grumley@providence.org

Locations

John Wayne Cancer Institute, Providence Saint John's Health Center

Recruiting

Santa Monica, California, United States, 90404

Contacts

Janie Grumley, MD

310-582-7100janie.grumley@providence.org

More Information

Sponsor

Saint John's Cancer Institute

Last update posted

Apr 16, 2024

Last verified

Apr, 2024

Keywords

  • Breast Cancer
  • Early-stage Breast Cancer
  • Intraoperative Radiotherapy
  • IORT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Saint John's Cancer Institute on 2024-04-16.