PIRATES: Image-guided Hyper-fractioned Dose-escalation With Proton Therapy for Head and Neck Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen
About this trial
In this study the safety \& feasibility of image-guided mid-treatment hyper-fractioned dose-escalation with proton therapy will be assessed for the treatment of locally advanced HPV-negative squamous cell oropharyngeal cancer
Eligibility criteria
Qualifiers
Biopsy proven diagnosis of squamous cell carcinoma originating in the oropharynx.
Routine staging procedures, including CT of the head and neck region and chest, head and neck FDG-PET/CT and MRI (treatment planning allowed), and endoscopic evaluation when indicated.
Negative for p16
Stage III-IV
Disqualifiers
underwent definitive resection of their primary tumor or nodal disease, except for incisional or excisional biopsies.
have no detectable tumor anymore at both the primary site and lymph nodes at week 4 in treatment, because there will not be a volume to boost.
are unable or unwilling to give written, informed consent
have contra-indications for chemotherapy. This is at the discretion of the treating medical oncologist.
Trial design
Treatments tested in this trial
- Image guided hybrid hyper-fractioned dose escalation with proton therapy
Treatment groups
17 Participants
are divided into 1 treatment groupSponsors and collaborators
University Medical Center Groningen
Lead sponsor
M.D. Anderson Cancer Center
Collaborator
Source ClinicalTrials.gov