Clinical trial · Interventional
Medico Economic Study, Comparing Intrabeam® on Surgical Resection Bed to Conventional Surgery + EBRT, in Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low-risk Breast Cancer | — | UNRESOLVED | — |
| Menopausal Patients | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery +RTE | Radiation | — | UNRESOLVED |
| RIOP-Intrabeam® system | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RIOP-Intrabeam® system
- description
- 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.
- interventionNames
- Radiation: RIOP-Intrabeam® system
- type
- ACTIVE_COMPARATOR
- label
- conventional surgery +RTE
- description
- surgery, EBRT over 33 sessions then visit at 6 months then every 6 months 6 for 5 years, then every year after 5 years.
- interventionNames
- Radiation: conventional surgery +RTE
Primary outcomes (1)
- measure
- Actual cost
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 55 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available