Exclusive Intraoperative Radiation Therapy for Breast Cancer

May 23, 2017 updated by: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genoa, Italy, 16132
        • IRCCS AOU San Martino- IST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early toxicity
Time Frame: 6 months
Assessment of early toxicity using modified RTOG scale
6 months
Late toxicity
Time Frame: 5 years
Assessment of late toxicity using modified LENT scale
5 years
Cosmetic outcome
Time Frame: 5 years
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)
Time Frame: 10 years
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)
Time Frame: 10 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Investigators

  • Principal Investigator: Marina Guenzi, MD, IRCCS AOU SanMartino IST

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

January 13, 2011

First Submitted That Met QC Criteria

January 13, 2011

First Posted (Estimate)

January 14, 2011

Study Record Updates

Last Update Posted (Actual)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • istgeiort

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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