Menopausal Patients Clinical Trial
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
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
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06254118 -
Treatment of Periodontitis in Menopausal Patients
|
Phase 4 |