Single Fraction Intraoperative Radiotherapy

Study Overview
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Brief Summary
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This clinical trial is being conducted to find out the effects (good and bad) of giving the full radiation treatment for breast cancer as a single dose of radiation during surgery for breast cancer. This single fraction intraoperative radiotherapy with electrons will study the toxicity, local control and cosmetic outcome.

Detailed Description
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For patients with certain types of breast cancer, one standard treatment is breast conserving surgery or lumpectomy (surgery to remove abnormal tissue or cancer from the breast and a small amount of normal tissue around it) followed by breast radiation. The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks followed by 5-8 daily localized irradiation (or boost) treatments at the site where the lump was removed. During this study, the single dose of electron irradiation given at the surgical site during the operation will replace the radiation given after surgery.

Official Title
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Single Fraction Intraoperative Radiotherapy With Electrons: An Option in Breast-Conserving Operable Breast Cancer Stages 0, I and II - Prospective, Single-arm Trial

Conditions
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Invasive Ductal and Invasive Lobular Breast Carcinoma, Stage 0 Breast Carcinoma, Stage I Breast Carcinoma, Stage II Breast Carcinoma

Intervention / Treatment
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* Procedure: Intraoperative Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological proven invasive breast carcinoma ductal, lobular and/or Ductal Carcinoma in situ Age > 40 years Karnofsky performance status > 70% Tumor. Single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of equal to or less than 2.5 cm Nodal Status: preoperatively N0 Clear surgical margins: R0 All grades G1 - G3 Any hormonal receptor and HER-2 status Informed consent Exclusion Criteria: Gender: male Tumor size: more than 2.5 cm Nodal status greater than or equal to N1 pathologically Multicentricity Previous radiotherapy to the involved breast Karnofsky Index < 70% Mixed connective tissue diseases e.g. rheumatoid poly arthritis, thromboangitis obliterans, systemic lupus Distant metastases Pregnancy in woman of child bearing age Unable to provide written consent

Ages Eligible for Study
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Minimum Age: 41 Years
Maximum Age: 90 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 |
| --- | --- |
| Experimental: IORT Arm<br>Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. | Procedure: Intraoperative Radiotherapy<br>* Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. IORT is performed on mobile or fixed linacs with variable electron energies in the range of 6-12 MeV prescribed to a dose of 21 Gy, with the prescription dose covering at least 90% of the Planning Target Volume (PTV). PTV is defined as a 3D volume of 1-2 cm beyond the former macroscopic tumor edge (excluding skin, limit to anterior rib surface: 5 Gy). The choice of electron energy as well as the cone applicator size has to account for minimum PTV requirements. Tissue depth measurement will be documented by intraoperative sonography.<br>* Other names: IORT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity Assessment | Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - system: End of initial surgical phase: Week 1, 4 First Follow-up investigation: Month 2 Assessment of late toxicity according to NSABP scoring-systems at 6, 12, 24, 36, 48, and 60 months | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic Evaluation | Assessment of cosmetic outcome according to 5-point scoring system Week 1, 2; Month 2, 6, 12, 24, 36, 48, 60 At yearly follow-up (photodocumentation in standardized positions) for 5 years | 5 years | 
| Recurrence Assessment | Recurrence is assessed at month 6, 12, 24, 36, 48, 60 | 5 years | 

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