Spots Global Cancer Trial Database for Radiotherapy in Preoperative Setting With CyberKnife for Breast Cancer
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Trial Identification
Brief Title: Radiotherapy in Preoperative Setting With CyberKnife for Breast Cancer
Official Title: Radiotherapy in Preoperative Setting With CyberKnife as Treatment in Early Breast Cancer: an Explorative Study
Study ID: NCT03520894
Conditions
Interventions
Study Description
Brief Summary: The aim of this study is to prospectively evaluate, in patients affected by early breast cancer, safety and feasibility of single fraction radiotherapy with Cyberknife R in preoperative setting, and to identify factors predictive for outcome based on biologic and clinical parameters.
Detailed Description: Monocentric, open-label, single-arm phase II study evaluating safety and efficacy of neoadjuvant radiotherapy in early breast cancer patients. Patients eligible are women aged 50 or more years old, affected by histologically proven invasive breast cancer, with positive hormonal receptors, grading 1 or 2, HER-2 negative, without lymphovascular invasion, and tumour size up to 2 cm (measured on mammography, ultrasound or magnetic resonance), negative clinical nodal status, eligible for BCS.
Keywords
Eligibility
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Azienda Ospedaliero Universitaria Careggi, Florence, , Italy
Contact Details
Name: Lorenzo Livi, Prof
Affiliation: AOU Careggi
Role: STUDY_CHAIR
Name: Icro Meattini, Prof
Affiliation: AOU Careggi
Role: STUDY_CHAIR
Name: Giulio Francolini, MD
Affiliation: AOU Careggi
Role: PRINCIPAL_INVESTIGATOR
Name: Vanessa Di Cataldo, MD
Affiliation: AOU Careggi
Role: PRINCIPAL_INVESTIGATOR
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