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

Breast Neoplasms Clinical Trial

Official title:

Research Registry for Intra-Operative Radiotherapy (IORT) During Breast Conserving Surgery in Patients With in Situ and Early Stage Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04603209
• Other study ID #: STUDY2019000317
• Status: Recruiting
• Start date: October 3, 2018
• Est. completion date: October 3, 2028

Study information

• Verified date: April 2024
• Source: Saint John's Cancer Institute
• Contact: Janie Grumley, MD
• Phone: (310) 582-7100
• Email: janie.grumley[@]providence.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

At Providence Saint John's Health Center, there is the ongoing integration of Intra-Operative Radiation Therapy (IORT) as a standard treatment option among Breast Conserving Therapy (BCT) for individuals with in situ and early stage breast cancer. Currently, approximately 60 women per year are being treated with IORT. No repository of information of patient outcomes with this treatment has been established. This leaves a critical gap in the ability to assess the long-term outcomes of patients treated with IORT.

As the practice of using IORT to treat early stage and in situ breast cancer continues to grow at Providence Saint John's Health Center, this registry will provide the data needed to compare patient outcomes with those being treated with the traditional whole breast radiation therapy. In addition, the Providence Health & Services strives to improve patient care and outcomes with excellence whenever possible. The registry will provide the data needed to compare patient outcomes to national and community standards that can inform internal practice patterns and contribute to advancing breast cancer care nationally and internationally.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 3, 2028
• Est. primary completion date: October 3, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma in Situ
• Breast Neoplasms
• Carcinoma in Situ
• Early-stage Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United States	John Wayne Cancer Institute, Providence Saint John's Health Center	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Saint John's Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Recurrence	Presence of recurrent tumor in ipsilateral breast or distant site	5 years
Secondary	Disease specific survival	survival	10 years
Secondary	Overall Survival	survival	10 years