Intraoperative Radiotherapy After Local Recurrence in Breast Cancer (RE-IORT01)

October 31, 2023 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Feasibility Clinical Trial of Intraoperative Radiotherapy (IORT) and Second Breast-conserving-surgery After Local Recurrence of Breast Carcinoma

The investigators propose a prospective, multicenter, single arm Phase II design to evaluate the feasibility of repeated breast-conserving surgery combined with re- irradiation using IORT after local recurrence of breast carcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Currently, the rate of ipsilateral breast tumor recurrence (IBTR) after breast- conserving surgery and radiotherapy remains at 10% at 10 years to 15% at 20 years, respectively. IBTR is an independent predictor of poor survival with a 3 to 4.6 increased risk of cancer-related death.

In a heterogeneous population, local control remains a major therapeutic challenge for these relapses, especially those considered of better prognosis, namely occurring late and of low histological grade. Therapeutic de-escalation is possible for these relapses to avoid a mutilating and often traumatic mastectomy.

However, this second conservative surgery has a high rate of second local relapse (19 to 50% at 5 years) due to the absence of a re-irradiation, rendered impossible by the problem of tolerance of previously irradiated tissues.

Retrospective or prospective studies on partial breast irradiation (PBI) in adjuvant setting report promising results, both in terms of tolerance (saving healthy tissue) and local control (74% to 100% at 5 years). Used techniques include brachytherapy, external beam radiotherapy and intraoperative radiotherapy (IORT).

IORT is now the subject of renewed interest in breast cancer. It has the advantages of high-precision ballistics on the operated area and of preservation of healthy tissue. To date, no prospective data, however, have been published in the indication of ipsilateral breast recurrence.

A prospective, multicenter, single arm Phase II design will evaluate the feasibility of repeated breast-conserving surgery combined with re- irradiation using IORT after local recurrence of breast carcinoma.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

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

  • France
      • Bordeaux, France, 33000
        • Institut Bergonie
      • Brest, France
        • CHU Brest
      • Dijon, France
        • Centre George François Leclerc
      • Lyon, France, 69
        • Centre Léon Bérard
      • Marseille, France, 13
        • CHU La Timone
      • Marseille, France, 13
        • Institut Paoli Calmette
      • Montpellier, France, 34298
        • ICM
      • Nantes, France
        • Institut de Cancérologie de l'Ouest

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically proven non-lobular invasive breast recurrence
  • Time from whole breast radiation following the initial lumpectomy >5 years
  • Unifocal tumor
  • Recurrent tumor size ≤ 2 cm
  • Adequate breast size for a second breast-conserving surgery with acceptable cosmetic result
  • Bilateral breast mammogram within 90 days prior to study entry
  • Breast MRI within 90 days prior to study entry
  • Histological grade I-II
  • Estrogen-receptor-positive tumor (ER+)
  • Cerb2-negative tumor
  • N0
  • M0
  • Prior radiotherapy delivered within a standard fractionation schedule
  • Performance status (ECOG) 0-1
  • Women ≥ 50 years -Absence of any psychological, familial, sociological, or geographical conditions with a potential to hamper compliance with the study and follow- up schedule
  • Affiliated to the French Health Insurance regimen
  • Written and signed informed consent form.

Exclusion Criteria:

  • Multifocal and/or multicenter recurrence
  • Lobular carcinoma
  • Estrogen-receptor-negative tumor (ER-)
  • Cerb2 (her2) overexpressed - breast cancer
  • Extensive intraductal component (EIC) on biopsy
  • Lymph vessel invasion on biopsy
  • N1-3 status: Regional cytological or histologically proven node recurrence
  • M1 status: Metastatic disease
  • cT4 (Skin or muscle involvement) or Paget's disease of the nipple
  • Prior radiotherapy delivered within an accelerated or hypo-fraction schedule
  • Prior malignancy other than non-melanoma skin cancer unless the patient has been disease free for at least 5 years
  • Patients with a small breast volume, technically unsatisfactory for a second conservative surgery or intraoperative breast irradiation.
  • Preoperative chemotherapy or hormone therapy for local relapse
  • Connective tissue disease or scleroderma, contraindicating radiotherapy
  • Known BRCA1/2 gene mutation (genetic testing is not required)

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: surgery and Intra Operative Radiotherapy

Surgery :

Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.

Intra Operative Radiotherapy (IORT):

After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure.
Procedure: tumorectomy
Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Radiation: Intra Operative Radiotherapy
After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The tolerance of RIOP (Intra Operative Radiotherapy) in patients with delayed local recurrences, after a second conservative treatment of breast cancer
Time Frame: Up ti 12 months post radiation
Fibrosis rate of RIOP grade 2 at 12 months of IORT (Intra Operative Radiotherapy) according to NCI CTCAE v4.0 classification
Up ti 12 months post radiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmetic outcome evaluated by photography
Time Frame: before treatment, at 15 days, at 3, 6, 12 and 24 months
A esthetic evaluation (photographs)
before treatment, at 15 days, at 3, 6, 12 and 24 months
Rate of early and late toxicities
Time Frame: from the baseline to 5 years after treatment
Rate of Early toxicities (Hematoma, Lymphorrhea, Breast infection) Late toxicities (telangiectasia, breast pain, skin hyperpigmentation, skin ulceration, skin atrophy)
from the baseline to 5 years after treatment
Local relapse-free survival
Time Frame: from the baseline to 5 years after treatment
Time from baseline to the apparition of local relapse
from the baseline to 5 years after treatment
Metastasis relapse-free survival
Time Frame: from the baseline to 5 years after treatment
Time from baseline to the apparition of metastatic relapse
from the baseline to 5 years after treatment
Disease-free survival.
Time Frame: from the baseline to 5 years after treatment
Time without relapse
from the baseline to 5 years after treatment
Overall survival
Time Frame: from the baseline to 5 years after treatment
Time from baseline to the apparition of relapse
from the baseline to 5 years after treatment
Free interval without mastectomy.
Time Frame: from the baseline to 5 years after treatment
Time from baseline to the mastectomy
from the baseline to 5 years after treatment

Collaborators and Investigators

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

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: LEMANSKI Claire, Institut régional du Cancer - Val d'Aurelle

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 (Actual)

March 1, 2014

Primary Completion (Actual)

June 12, 2020

Study Completion (Actual)

September 18, 2023

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimated)

March 11, 2015

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM-URC2014/07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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