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

  • STATUS
    Recruiting
  • End date
    Dec 5, 2030
  • participants needed
    519
  • sponsor
    Institut du Cancer de Montpellier - Val d'Aurelle
Updated on 19 February 2024
cancer
estrogen
breast cancer
breast carcinoma
breast cancer stage
sentinel node
estrogen receptor
breast-conserving surgery
breast cancer staging
partial breast irradiation
lymph node dissection
tumorectomy
radiation oncology

Summary

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.

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

Details
Condition Mastectomy, Mastectomy, Partial Mastectomy, Invasive Breast Cancer
Age 60years - 100years
Treatment tumorectomy with axillary dissection (sentinel lymph node), per-operative partial irradiation
Clinical Study IdentifierNCT04414202
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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