Intraoperative Radiation Therapy in Early Stage Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Intraoperative Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Inclusion Criteria Age ≥ 45 years. Clinical stage Tis, T1, T2 (≤ 3cm), N0, M0 (AJCC Classification). Invasive ductal or lobular carcinoma, DCIS and/ or pleomorphic lobular carcinoma in situ. Exclusion Criteria: Scleroderma, systemic sclerosis and active lupus. Participation in an investigational drug or device study. Previous ipsilateral radiation to the thorax or breast. Multifocal breast cancer. Pregnant patients. Patient not competent to provide informed consent. Neoadjuvant systemic therapy. Lymphovascular invasion on biopsy pathology

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>Patients treated with intraoperative radiation therapy at the time of partial mastectomy. | Radiation: Intraoperative Radiation Therapy<br>* Intraoperative radiation therapy at the time of partial mastectomy in early stage breast cancer<br>* Other names: IORT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Disease Relapse | 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). | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease specific and overall survival | Disease specific and overall survival will be obtained for all patients in the study. | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IORT, Breast Cancer