Medico Economic Study, Comparing Intrabeam® on Surgical Resection Bed to Conventional Surgery + EBRT, in Breast Cancer (RIOP-SEIN)

Medico Economic Study, Randomized, Comparing Intraoperative Radiotherapy With Intrabeam® on Surgical Resection Bed Versus Conventional Surgery + EBRT in Postmenopausal Patients Operated by Conservative Surgery for Low Risk Breast Cancer

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

Study Overview

• Status: Active, not recruiting
• Conditions: Menopausal Patients; Low-risk Breast Cancer
• Intervention / Treatment: Radiation: RIOP-Intrabeam® system; Radiation: conventional surgery +RTE

Detailed Description

Main objective is the economic comparison Intrabeam® system versus EBRT, in terms of real costs. Costs will be taken into account:

• of equipment,
• of staff,
• of transport.

Secondary objectives are :

• Compare local-regional survival without recurrence with conventional irradiation
• Analyze the rate of early and late complications
• Impact of intraoperative irradiation on the esthetic outcome and quality of life of patients

Schedule of the visits :

RIOP arm : Surgery with Intrabeam®. A first visit will be scheduled at 2 months from surgery then at 6 months then every 6 months for 5 years, then every year after 5 years.

RTE arm: surgery, EBRT over 33 sessions then visit at 6 months then every 6 months 6 for 5 years, then every year after 5 years.

In RIOP ARM, additional EBRT may be performed +/- chemotherapy if the treatment received is insufficient.

Quality of life will be assessed in each treatment arm at inclusion before randomization, 2 months after surgery, every 6 months for 5 years and every year after 5 years using quality of life questionnaires: Euroqol EQ 5D, European Organisation for Research and Treatment of Cancer (EORTC)-QlQ-C30 and BR23 module specific for breast cancer.

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Institut Bergonie
  • Brest, France, 29609
    • CHU Morvan
  • Dijon, France, 21079
    • Centre G F Leclerc
  • Lyon, France, 69 000
    • Centre Leon Berard
  • Marseille, France, 13009
    • Institut Paoli Calmette
  • Montpellier, France, 34298
    • INSTITUT REGIONAL DU CANCER MONTPELLIER - Val D'Aurelle
  • Paris, France, 75000
    • Hopital Saint Louis
  • Saint Herblain, France, 44805
    • Centre René Gauducheau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Histologically proven invasive ductal breast cancer,
• Menopausal women at least 55 years old,
• Clinical and ultrasound size ≤ to 20 mm, N0,
• Biopsy with all following criteria: SBR I or II, HER2 (0, +, ++ with FISH or SISH required), positive estrogen receptors, no embolus
• No personal history of breast cancer or BRCA gene mutation.
• Social insurance
• Signed consent

Exclusion Criteria:

• Bifocal or bilateral breast cancer,
• Presence of invasive ductal carcinoma with diffuse micro calcifications on mammography,
• Invasive lobular carcinoma,
• Presence of lymph node involvement,
• History of malignant disease if life expectancy without recurrence at 10 years <90%,
• Adult under guardianship,
• History of chest radiation therapy (Hodgkin's).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIOP-Intrabeam® system; Surgery with Intrabeam®. A first visit will be scheduled at 2 months from surgery then at 6 months then every 6 months for 5 years, then every year after 5 years. Additional EBRT may be performed +/- chemotherapy if the treatment received is insufficient.	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.
Active Comparator: conventional surgery +RTE; surgery, EBRT over 33 sessions then visit at 6 months then every 6 months 6 for 5 years, then every year after 5 years.	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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actual cost	Actual cost measured individually for each patient for both techniques used, involving all costs from surgery to 2 months after the end of radiotherapy including costs related to possible acute complications of radiotherapy	2 months after the end of radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local-regional recurrence rate	Analysis of the local-regional relapse rate with Intrabeam system as compared with the results published with EBRT	10 years
Complication rates	Early and late complication rates	10 years
Esthetic result	Taking photos at inclusion, 2 months, 1 year, 5 years and 10 years from the end of radiotherapy	10 years
quality of life after surgery and radiotherapy	questionnaires EQ 5D	10 years
quality of life after surgery and radiotherapy	questionnaires EORTC-QLQ-C30	10 years
quality of life after surgery and radiotherapy	questionnaires BR23	10 years

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Investigators: Principal Investigator: MAGALI LE BLANC, MD, ICO Nantes

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): August 1, 2014
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Intrabeam®; intraoperative radiation therapy; conventional external radiotherapy; conservative surgery
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ICO-2012-03

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