Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis (INTRA-OBS)

April 10, 2026 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Due to screening, T1N0 early-stage breast cancer now accounts for more than 50% of the tumors diagnosed in France. The prognosis of these tumors is good, even excellent in women ≥ 65 years of age, with specific survival of 98% at 5 years.

The treatment of these tumors combines breast-conserving surgery and external whole breast irradiation for 6.5 weeks.

A true de-escalation of treatment is taking place with these tumors, both surgically and medically. Surgery therefore now prefers breast-conserving methods in combination with exeresis of the sentinel lymph node only. In the same way, in many international studies, radiotherapy has been evaluating the possibility of reducing both:

  • the irradiation volume at the excision site (partial irradiation)
  • the duration of this irradiation (accelerated radiotherapy)

Between 2004 and 2007, the CRLC [Regional Anti-Cancer Center] evaluated the feasibility and the oncological results of intra-operative partial irradiation via a phase II study in women 65 years of age and older with T1N0M0 hormone-sensitive tumors with a good prognosis.

From 2010 to 2013, the ICM carried out an observational study of these tumors with an excellent prognosis.

In July 2009, the American Society for Radiation Oncology (ASTRO) published a consensus statement with specific recommendations and indications for accelerated partial breast irradiation (APBI).

This APBI technique has been developing in France over the past 5 years within the framework of clinical studies and in compliance with the 2012 recommendations of the French National Cancer Institute. This APBI can be given by 3D external radiotherapy or, as in this study, by intra-operative radiotherapy (IORT) in order to obtain optimal precision and spare as much of the surrounding healthy tissue as possible.

The Investigator therefore propose a cohort study to prospectively analyze the results of this technique applied to the indications strictly defined by the ASTRO.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

after registration, particpants have as treatment "combination extended tumorectomy with axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial irradiation at the tumor site.

follow up after this treatment during 5 years

Study Type

Observational

Enrollment (Actual)

519

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
    • Herault
      • Montpellier, Herault, France, 34398
        • ICM 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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Invasive breast cancer with a good prognosis that is accessible to breast-conserving surgery

Description

Inclusion Criteria:

  • Women 60 years of age or older,

  • Histologically proven invasive ductal breast cancer or of a histologically favorable sub-type (mucinous, tubular or colloid),

    -. Unifocal tumor,

  • T1 (diameter ≤ 20 mm),
  • N0 (pN0 or pNi+),
  • M0,
  • Gland exeresis margins ≥ 2 mm,
  • Estrogen receptor positive,
  • Information and non-opposition of the patient.

Exclusion Criteria:

-. Inflammatory breast cancer,

  • Associated peri-tumoral lymphatic emboli
  • Associated extensive intra-ductal component
  • Invasive lobular carcinoma
  • Pure ductal carcinoma in situ,
  • Sarcoma or lymphoma-type non-epithelial tumor
  • Synchronous bilateral breast cancer,
  • Any prior neo-adjuvant treatment: radiotherapy, chemotherapy, hormone therapy

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1 GROUP

Patient with an Invasive breast cancer with a good prognosis that is accessible to breast-conserving surgery.

The treatment combines extended tumorectomy with axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial irradiation at the tumor Follow up after this treatment will scheduled 10 years
Procedure: tumorectomy with axillary dissection (sentinel lymph node)
All patients will have local excision of the primary tumor following appropriate clinical work-up. Surgery will be done according to usual local practice with a complete excision of the tumor. The aim of the local excision should be to achieve a minimum free margin of 2 mm whilst maintaining a good cosmetic outcome.
Radiation: per-operative partial irradiation
20 Gy of per-operative partial irradiation at the tumor site during the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patient With a Local Intra-mammary Relapse
Time Frame: post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)
The local relapse rate, defined as the number of intramammary relapses in the treated breast (regardless of quadrant and including skin), appreciated at 5 years and 10 years. It will be assessed according to the recommendations applied to the Centre
post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmetic Results
Time Frame: post surgery : 3 weeks, 6 months and 12 months
Evaluation of the cosmetic result of questionnaire (0 "no satisfy with the cosmetic result"" from 10 "very satisfy with the cosmetic result")
post surgery : 3 weeks, 6 months and 12 months
Patients' Satisfaction Towards the Treatment
Time Frame: post surgery : 3 weeks, 6 months and 12 months
Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)
post surgery : 3 weeks, 6 months and 12 months
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
Time Frame: post surgery : 3 weeks, 6 months and 12 months
Assessment of the impact of this accelerated treatment on maintaining the autonomy of the subject by the use of geriatric scale (ADL (Activities of Daily Living), IADL (instrumental Activities of Daily Living)). (scale from 0 "no autonomy" to 10 "good autonomy")
post surgery : 3 weeks, 6 months and 12 months
Overall Survival
Time Frame: from baseline to 10 years after treatment
rate of death
from baseline to 10 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, DR, ICM Val d'Aurelle DRCI

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

Helpful Links

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)

December 15, 2009

Primary Completion (Actual)

October 16, 2023

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/OBS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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