Exclusive Intraoperative Radiation Therapy for Breast Cancer

Study Overview
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Brief Summary
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Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy

Official Title
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Tolerance Evaluation of Exclusive Intraoperative Radiation Therapy at Different Doses for Breast Cancer Conservative Treatment

Conditions
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Breast Neoplasms, Toxicity

Intervention / Treatment
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* Radiation: 21 Gy radiation
* Radiation: 18 Gy radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non lobular epithelial breast carcinoma, excised with standard quadrantectomy Age ≥ 45 and < 85 Tumor major diameter ≤ 2.5 cm Negative surgical margins (≥ 5 mm) Willingness to undergo follow up examinations Willingness to undergo imaging examinations (MRI, mammograms, ultrasonography) Signed informed consent Exclusion Criteria: Ductal carcinoma in situ or lobular carcinoma Extensive intraductal component (greater than 25%) or intraductal carcinoma with microinvasion Serious concomitant disease or any disorder or condition (such as psychiatric or addictive disorders) that, in the opinion of the investigator, would preclude the patient from meeting the study requirements Pregnancy or lactation at the time of enrolment proposal (if necessary, during the trial patients must use effective contraceptive device) Collagen vascular disorders

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IORT 21 Gy<br>Single fraction 21 Gy Intraoperative Radiation Therapy for breast tumors with diameter between 10 and 25 mm | Radiation: 21 Gy radiation<br>* 21 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)<br>|
| Experimental: IORT 18 Gy<br>Single fraction 18 Gy Intra Operative Radiation Therapy in breast tumors smaller than 10 mm. | Radiation: 18 Gy radiation<br>* 18 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early toxicity | Assessment of early toxicity using modified RTOG scale | 6 months | 
| Late toxicity | Assessment of late toxicity using modified LENT scale | 5 years | 
| Cosmetic outcome | Assessment of cosmetic outcome according to semi-objective criteria | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Relapse Free Survival (LRFS) | Local recurrence rate will be continuously monitored in order to stop the trial in case results will be consistently worse than expected according to literature data | 10 years | 
| Disease Free Survival (DFS) | Disease Free Survival will be continuously monitored in order to stop the trial in case results will be consistently worse than expected according to literature data | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Intra Operative Radiation Therapy, Toxicity