Title Stereotactic Boost and SHOrt-course Radiation Therapy for HPV-associated OroPharynx Cancer Trial: A Randomized Multicentric Phase II Trial
Protocole ID SHORT-OPC
ClinicalTrials.gov ID NCT04178174
Cancer Type(s) Head and Neck
Phase Phase II
Stage
Study Type Clinical
Drug
Institution CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
City
Principal Investigator Dr. Houda Bahig
Coordinator Mom Phat
514-890-8000 poste 11171
Status Recruiting
Activation Date
Eligibility Criteria
  • 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.
  • Positive for HPV by p16 immunohistochemistry (IHC) or HPV in-situ hybridization (ISH)
  • Clinical stage T1-3, N1 M0 (Stage I-II) as per AJCC 8th edition.
  • Primary tumor < 30 cc
  • Planned for curative chemoradiation
  • For females of child-bearing age, a negative pregnancy test
Exclusion Criteria
  • Previous irradiation of the head and neck (HNC) region
  • Previous surgery of the HNC region (except for incisional or excisional biopsies)
  • Pregnancy or breastfeeding
  • Connective tissue disease
  • Any medical condition that could, in the opinion of the investigator, prevent follow-up after radiotherapy.
  • Non-Cisplatin concurrent chemotherapy
  • Prior induction chemotherapy