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Medico Economic Study, Comparing Intrabeam® on Surgical Resection Bed to Conventional Surgery + EBRT, in Breast Cancer

NCT03637738 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2018-08-20

No results posted yet for this study

Summary

Current breast cancer treatment is based on surgery, radiation, chemotherapy and hormonotherapy. Conservative surgery or mastectomy are followed by complementary externe radiotherapy.

This adjuvant external breast radiotherapy (EBRT) is heavy, spread over more than 6 weeks with :

* 25 sessions and delivery of a unit dose of 2 Gy to obtain a total dose of 50 Gy (5 sessions per week in general);
* 16 Gy overimpression (boost) dose located in the tumour bed, in 5 to 8 fractions, in situations at high risk of recurrence.

In addition, EBRT is responsible for many adverse effects, some of which can lead to lasting or permanent sequelae.

Many focused partial breast irradiation techniques have been developed in recent years with the objective of reducing the duration and morbidity of overall breast irradiation.

Among these techniques, intraoperative breast radiotherapy (IBRT) is recommended in cancers diagnosed at early stages for which tumorectomy is expected and which present a low risk of recurrence.

The main advantages of IBRTare :

* Improvement of the quality of life due to a single session of radiotherapy associated with surgical ;
* Increased precision to deliver the necessary dose in tumour tissue;
* Preservation of surrounding healthy tissue ;
* Reduction in the overall cost of treatment through shorter hospital stays and the absence of medical transport for conventional radiotherapy sessions.

RIOP SEIN is a project supported by Institut National du Cancer (INCa)

, which consists of a medico-economic evaluation of IBRT, with Intrabeam® system on surgical resection bed relative to conventional surgery + EBRT in postmenopausal patients operated by conservative surgery for Low risk breast cancer

Conditions

  • Menopausal Patients
  • Low-risk Breast Cancer

Interventions

RADIATION

RIOP-Intrabeam® system

The radiation source is inserted at the immediately on surgical resection bed after tumorectomy and started for 20 to 55 minutes to perform intraoperative radiotherapy precisely targeting the tissues that present the greatest risk of local recurrence. The applied dose will be 20 Gy on the applicator surface.

RADIATION

conventional surgery +RTE

Conventional EBRT, 5 to 10 weeks after surgery, according to the usual recommendations, 2 Gy per session, 5 sessions per week, with a total dose on the mammary gland of 50 Gy + a boost of 16 Gy on surgical resection bed .

Sponsors & Collaborators

  • Institut Cancerologie de l'Ouest

    lead OTHER

Principal Investigators

  • MAGALI LE BLANC, MD · ICO NANTES

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-08-31
Completion
2024-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03637738 on ClinicalTrials.gov