Neoadjuvant DaRT for Locally Advanced Oral Cavity SCC
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlpha Tau Medical LTD.
About this trial
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device (DaRT) as a treatment prior to additional radiation or chemo therapy.
Eligibility criteria
Qualifiers
Pathologically confirmed, previously untreated, resectable squamous cell carcinoma of the oral cavity (no involvement of the lips);
T1-T2, N1-N2; T3 N0-2 with T3 <5 cm, depth of infiltration <15 mm, (AJCC version 8 oral cavity);
Tumor must be potentially curable by conventional methods;
Primary tumor must be amenable for complete coverage (including margins) by the DaRT seeds;
Disqualifiers
Floor-of-mouth primaries or extension onto the floor-of-mouth;
Documented evidence of distant metastases (M1) based on a diagnostic, contrast-enhanced whole-body PET-CT scan ;
Any previous anti-cancer therapy for HNSCC (surgery, chemo, radiotherapy or molecularly targeted therapy);
Malignancy treated with curative intent and with no known active disease ≥2 years before enrolment and of low potential risk for recurrence
Trial design
Treatments tested in this trial
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT
Treatment groups
79 Participants
are divided into 1 treatment groupSponsors and collaborators
Alpha Tau Medical LTD.
Lead sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborator
Source ClinicalTrials.gov