Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
About this trial
This is a randomized clinical trial comparing the outcomes of short-course chemoradiation consisting in stereotactic boost to the gross tumor and de-esclalated chemoradiation to the elective neck in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation.
Eligibility criteria
Qualifiers
Age ≥18 years
Ability to provide written informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.
Disqualifiers
Clinical N3 classification, as per AJCC 8th edition
Clinically overt extranodal extension (ENE). As per AJCC 8th edition, clinically overt ENE is defined as invasion of the skin, infiltration of musculature/fixation to adjacent structures on clinical examination, cranial nerve, brachial plexus, sympathetic trunk or phrenic nerve invasion with dysfunction).
Previous irradiation of the head and neck region
Previous surgery of the HNC region (except for incisional or excisional biopsies)
Trial design
Treatments tested in this trial
- SABR boost and de-escalated chemoradiation
- Standard chemoradiation
Treatment groups
360 Participants
are divided into 2 treatment groupsSponsors and collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
M.D. Anderson Cancer Center
Collaborator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborator
Jewish General Hospital
Collaborator
Source ClinicalTrials.gov