Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy
NCT ID: NCT05498311
Last Updated: 2022-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
89 participants
INTERVENTIONAL
2016-10-20
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intraoperative Radiotherapy (IORT)
Patients with diagnosis of invasive breast cancer (IBC) will be treated with conservative surgery (with or without oncoplastic surgery) and 20 Gy IORT followed by hypofractionated radiotherapy.
Intraoperative Radiotherapy (IORT)
The Intrabeam Photon Radiosurgery System will deliver 20 Gy in the act of breast surgery
Breast conservative surgery
Breast conservative surgery with the aim of resecting breast tumour and with or without oncoplastic surgery
External Beam Hypofractionated Radiotherapy (EBRT)
A External Beam Hypofractionated Radiotherapy will be administered after surgery. y. The dose per fraction will be 2.67 Gy per session. EBRT will be performed daily from Monday to Friday for fifteen fractions.
Interventions
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Intraoperative Radiotherapy (IORT)
The Intrabeam Photon Radiosurgery System will deliver 20 Gy in the act of breast surgery
Breast conservative surgery
Breast conservative surgery with the aim of resecting breast tumour and with or without oncoplastic surgery
External Beam Hypofractionated Radiotherapy (EBRT)
A External Beam Hypofractionated Radiotherapy will be administered after surgery. y. The dose per fraction will be 2.67 Gy per session. EBRT will be performed daily from Monday to Friday for fifteen fractions.
Eligibility Criteria
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Inclusion Criteria
* Not pregnant at diagnosis.
* Signed informed consent form.
* Age ≥45 years old.
* Patients candidates to Intrabeam.
* Patients with ≥60 years with the presence of one or more of the following adverse criteria after surgery:
* Tumor size \> 2.5 cm.
* Extensive intraductal carcinoma (≥25%)
* Lymphovascular invasion.
* Involved focal margins (\<2mm) without ampliation surgery.
Exclusion Criteria
* Primary chemotherapy.
* Lymph node involvement.
* Negative hormonal receptors.
* Diagnosis of any other infiltrating tumour except for adequately resected squamous or basal cell epitheliomas
* Patients with collagen vascular disease (systemic lupus erythematosus, scleroderma, dermatomyositis).
* Uncontrolled infection.
* Concurrent treatment with other experimental treatments
* Lack of signed informed consent form.
45 Years
FEMALE
Yes
Sponsors
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Institut Català d'Oncologia
OTHER
Responsible Party
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Principal Investigators
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Evelyn Martínez, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Català d'Oncologia
Locations
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Evelyn Martínez
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IORT BREAST CANCER
Identifier Type: -
Identifier Source: org_study_id
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