Radiation Therapy During Surgery in Treating Older Women With Stage I Breast Cancer (IORT-Sein)

March 3, 2025 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Phase 2 Study Evaluating the Feasibility and the Reproducibility of Concentrated Radiotherapy and Focalized Electrontherapy During Surgery for the Treatment of Older Patients With Breast Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving intraoperative radiation therapy may reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving radiation therapy during surgery works in treating older women with stage I breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Study the feasibility and reproducibility of intraoperative radiotherapy as the only treatment after lumpectomy in older women with stage I breast cancer.

Secondary

  • Study the impact of this regimen on maintaining self-care.
  • Study the quality of life (QLQ-C30) and satisfaction with care.
  • Study regimen tolerance and cosmetic results.
  • Evaluate the economic impact of this treatment.
  • Study relapse-free and disease-specific survival.

OUTLINE: Patients undergo conservative breast surgery and axillary node dissection (sentinel node or classic resection). At this point, patients must have either negative axillary lymph nodes after removal of ≥ 6 lymph nodes, negative sentinel nodes, or have had a limited lumpectomy with negative margins ≥ 2 mm. Patients undergo intraoperative radiotherapy during surgery, before closing and reconstruction of the breast.

Patients may begin hormonal therapy after completing study therapy.

After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Study Type

Interventional

Enrollment (Actual)

42

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
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Histologically confirmed stage I breast cancer

    • Size ≤ 20 mm (by ultrasound), N0, any quadrant
  • Hormone receptor status not specified

Exclusion criteria:

  • Distant metastases
  • Inflammatory breast cancer
  • Lobular in situ disease
  • Invasive cancer or ductal carcinoma in situ
  • Nonepithelial disease or sarcoma
  • Multicentric disease
  • Lymphatic embolism
  • Margins of safety unknown or positive (in situ or invasive)
  • Preoperative mammography showing diffuse microcalcification

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal
  • Karnofsky 70-100%
  • No other prior cancer except basal cell skin cancer, uterine epithelioma in situ, or other cancer in complete remission for the past 5 years
  • No geographic, social, or psychiatric reasons that would impede participation in study treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior neoadjuvant therapy
  • No concurrent participation in another study

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: treatment arm
breast conserving surgery with lymph node dissection + Intraoperative radiotherapy
Procedure: conventional surgery
Radiation: intraoperative radiation therapy
Procedure: sentinel lymph node biopsy
Procedure: axillary lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of feasibility of partial irradiation of the breast by per-operative electron therapy
Time Frame: During the treatment of irradiation (4 weeks)
feasibility based on dosimetric criteria based on the Quality Index of the application.
During the treatment of irradiation (4 weeks)
Evaluation of reproducibility of partial irradiation of the breast by per-operative electron therapy
Time Frame: During the treatment of irradiation (4 weeks)
reproducibility based on dosimetric criteria based on the Quality Index of the application.
During the treatment of irradiation (4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impact on Quality of life of partial irradiation of the breast by per-operative electron therapy
Time Frame: from the baseline to 12 months after the treatment
Impact described by th scores of "Instrumental Activities of Daily Living scale"
from the baseline to 12 months after the treatment
impact on Quality of life of partial irradiation of the breast by per-operative electron therapy
Time Frame: from the baseline to 12 months after the treatment
Impact described by th scores of "Activities of Daily Living scale"
from the baseline to 12 months after the treatment
Tolerability of partial irradiation of the breast by per-operative electron therapy
Time Frame: from the baseline to 12 months after the treatment
Tolerability done with Common Terminology Criteria for Adverse Events scale
from the baseline to 12 months after the treatment
Relapse-free survival
Time Frame: from the baseline to 12 months after the treatment
Relapse-free survival describes with radiologie evaluation
from the baseline to 12 months after the treatment
Disease-specific survival
Time Frame: from the baseline to 12 months after the treatment
Relapse-free survival describes with radiologie evaluation
from the baseline to 12 months after the 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: Jean-Bernard Dubois, MD, Institut du Cancer de Montpellier - 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)

April 19, 2004

Primary Completion (Actual)

December 31, 2008

Study Completion (Actual)

December 31, 2008

Study Registration Dates

First Submitted

November 9, 2007

First Submitted That Met QC Criteria

November 9, 2007

First Posted (Estimated)

November 12, 2007

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000574074
  • CLCC-IORT-Sein
  • INCA-RECF0284

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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