Intraoperative Radiation Therapy in Early Stage Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Radiation: Intraoperative Radiation Therapy

• Registration Number: NCT02266602
• Lead Sponsor: Benaroya Research Institute

Brief Summary

Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and early stage breast cancer.

Detailed Description

The purpose of this clinical study is to assess the effectiveness of IORT, using an electronic brachytherapy system, in patients with limited-volume in situ and early stage breast cancer, with endpoints of:

* Local recurrence in early stage breast cancer patients treated with IORT.

* Toxicity associated with IORT.

* Long-term disease-specific and overall survival

* Cosmetic results using the Harvard Scale at start and follow-up periods in patients treated with IORT.

* Quality of life in patients treated with IORT.

* Health care costs associated with IORT.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-14
• Study First Posted: 2014-10-17
• Primary Completion: 2018-07-30
• Study Completion: 2018-07-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

General Inclusion Criteria

1. Age ≥ 45 years.
2. Clinical stage Tis, T1, T2 (≤ 3cm), N0, M0 (AJCC Classification).
3. Invasive ductal or lobular carcinoma, DCIS and/ or pleomorphic lobular carcinoma in situ.

Exclusion Criteria

1. Scleroderma, systemic sclerosis and active lupus.
2. Participation in an investigational drug or device study.
3. Previous ipsilateral radiation to the thorax or breast.
4. Multifocal breast cancer.
5. Pregnant patients.
6. Patient not competent to provide informed consent.
7. Neoadjuvant systemic therapy.
8. Lymphovascular invasion on biopsy pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Intraoperative Radiation Therapy	Patients treated with intraoperative radiation therapy at the time of partial mastectomy.

Primary Outcome Measures

Name	Time	Method
Local Disease Relapse	10 years	Patients are evaluated clinically at 3 months, 6 months, 9 months, 1 year and every six months for 10 years for disease recurrence. In addition to clinical exams, yearly mammograms and other imaging studies as deemed appropriate will be obtained to rule out recurrent disease. Recurrent disease will be defined as cancer recurrence within 2cm of site of original tumor bed (marked by surgical clips).

Secondary Outcome Measures

Name	Time	Method
Disease specific and overall survival	10 years	Disease specific and overall survival will be obtained for all patients in the study.

Trial Locations

Locations (1)

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States