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Trial Title:
Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy
NCT ID:
NCT05498311
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Intraoperative radiotherapy
hypofractionated radiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Intraoperative Radiotherapy (IORT)
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Intraoperative Radiotherapy (IORT)
Description:
The Intrabeam Photon Radiosurgery System will deliver 20 Gy in the act of breast surgery
Arm group label:
Intraoperative Radiotherapy (IORT)
Intervention type:
Procedure
Intervention name:
Breast conservative surgery
Description:
Breast conservative surgery with the aim of resecting breast tumour and with or without
oncoplastic surgery
Arm group label:
Intraoperative Radiotherapy (IORT)
Intervention type:
Radiation
Intervention name:
External Beam Hypofractionated Radiotherapy (EBRT)
Description:
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.
Arm group label:
Intraoperative Radiotherapy (IORT)
Summary:
To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM
followed by hypofractionated external beam radiotherapy
Detailed description:
To evaluate cosmetic outcomes following conservative surgery (with or without oncoplastic
surgery) for breast cancer with intraoperative radiotherapy (INTRABEAM) followed by
hypofractionated external beam radiotherapy
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically-confirmed diagnosis of invasive breast carcinoma and eligibility for
conservative surgery (with or without oncoplastic surgery) and radiotherapy.
- 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:
- Presence of distant metastasis.
- 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.
Gender:
Female
Minimum age:
45 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Evelyn Martínez
Address:
City:
Hospitalet de Llobregat
Zip:
08908
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Evelyn Martínez, MD
Phone:
+34 93 260 77 20
Email:
emperez@iconcologia.net
Start date:
October 20, 2016
Completion date:
December 2024
Lead sponsor:
Agency:
Institut Català d'Oncologia
Agency class:
Other
Source:
Institut Català d'Oncologia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05498311