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

NCT03637738 | Unknown

• 1 other identifier: ICO-2012-03
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

Intrabeam®; intraoperative radiation therapy; conventional external radiotherapy; conservative surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Local-regional recurrence rate

  10 years

• Complication rates

  10 years

• Esthetic result

  10 years

• quality of life after surgery and radiotherapy

  10 years

• quality of life after surgery and radiotherapy

  10 years

Study Arms (2)

RIOP-Intrabeam® system

EXPERIMENTAL

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

conventional surgery +RTE

ACTIVE COMPARATOR

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

Interventions

RIOP-Intrabeam® system RADIATION

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.

RIOP-Intrabeam® system

conventional surgery +RTE RADIATION

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 .

conventional surgery +RTE

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (8)

Institut Bergonié

Bordeaux, 33000, France

Location

Chu Morvan

Brest, 29609, France

Location

Centre G F Leclerc

Dijon, 21079, France

Location

Centre Léon Berard

Lyon, 69 000, France

Location

Institut Paoli Calmette

Marseille, 13009, France

Location

INSTITUT REGIONAL DU CANCER MONTPELLIER - Val D'Aurelle

Montpellier, 34298, France

Location

Hôpital Saint Louis

Paris, 75000, France

Location

Centre René Gauducheau

Saint-Herblain, 44805, France

Location

Study Officials

• MAGALI LE BLANC, MD

  ICO NANTES

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Medico-economic, National Multicentric, Prospective, Randomized, Comparative, Open study of a medical device

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 20, 2018
• Study Start: June 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: May 1, 2024
• Last Updated: August 20, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)