Completed

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

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What is being tested

Intraoperative Radiotherapy

Procedure
Who is being recruted

Adenocarcinoma+11

+ Breast Diseases

+ Carcinoma in Situ

From 41 to 90 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2012
See protocol details

Summary

Principal SponsorSt. Joseph Hospital of Orange
Last updated: May 11, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01688388
Principal SponsorSt. Joseph Hospital of Orange
Last updated: May 11, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

250 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 41 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaBreast DiseasesCarcinoma in SituNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Ductal, Lobular, and MedullaryBreast Carcinoma In SituBreast NeoplasmsCarcinomaCarcinoma, Lobular

Criteria

9 inclusion criteria required to participate
Age > 40 years
All grades G1 - G3
Any hormonal receptor and HER-2 status
Clear surgical margins: R0
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10 exclusion criteria prevent from participating
Distant metastases
Gender: male
Karnofsky Index < 70%
Mixed connective tissue diseases e.g. rheumatoid poly arthritis, thromboangitis obliterans, systemic lupus
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

St. Joseph Hospital of Orange

Orange, United StatesOpen St. Joseph Hospital of Orange in Google Maps
CompletedOne Study Center