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

Menopausal Patients Clinical Trial

— RIOP-SEIN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03637738
• Other study ID #: ICO-2012-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2012
• Est. completion date: May 2024

Study information

• Verified date: August 2018
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 246
• Est. completion date: May 2024
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Neoplasms
• Low-risk Breast Cancer
• Menopausal Patients

Intervention

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.
• 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 .

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux
France	Chu Morvan	Brest
France	Centre G F Leclerc	Dijon
France	Centre Léon Berard	Lyon
France	Institut Paoli Calmette	Marseille
France	INSTITUT REGIONAL DU CANCER MONTPELLIER - Val D'Aurelle	Montpellier
France	Hôpital Saint Louis	Paris
France	Centre René Gauducheau	Saint Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

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