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NCT Number: NCT04414202

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

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.

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Key information

Conditions

Invasive Breast Cancer Breast Diseases Breast Neoplasms Breast-conserving Surgery Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

60 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Icm Val D'Aurelle

Montpellier, Herault, 34398, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tumorectomy with axillary dissection (sentinel lymph node)

Procedure

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.

per-operative partial irradiation

Radiation

20 Gy of per-operative partial irradiation at the tumor site during the surgery

Primary outcomes

  1. 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

Secondary outcomes

  1. 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")

  2. 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)

  3. 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")

  4. Overall Survival

    Time frame: from baseline to 10 years after treatment

    rate of death

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Acronym: INTRA-OBS

Important dates

Study start
2009
Primary completion
2023
Study completion
2030
First posted
Jun 4, 2020
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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