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

NCT04603209 | Recruiting

• 1 other identifier: STUDY2019000317
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Disease Recurrence

  Presence of recurrent tumor in ipsilateral breast or distant site

  5 years

Secondary Outcomes (2)

• Disease specific survival

  10 years

• Overall Survival

  10 years

Study Arms (1)

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.

Radiation: Intraoperative Radiation Therapy (IORT)

Interventions

Intraoperative Radiation Therapy (IORT) RADIATION

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

IORT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any individual aged ≥ 18 years with early stage breast cancer who is determined to be suitable candidates for breast-conserving surgery and IORT by a multidisciplinary team.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Saint John's Cancer Institute: lead

Study Sites (1)

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

Santa Monica, California, 90404, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Janie Grumley, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janie Grumley, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Comprehensive Breast Program, Margie Petersen Breast Center

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 26, 2020
• Study Start: October 3, 2018
• Primary Completion (Estimated): October 3, 2028
• Study Completion (Estimated): October 3, 2028
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

US (1)