ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
This study is a prospective phase II trial, designed to assess the efficacy and feasibility of adjuvant treatment deintensification guided by ctHPVDNA levels for patients with HPV+OPSCC who undergo transoral surgery and neck dissection.
Eligibility criteria
Qualifiers
Subjects ≥ 18 years old at the time of informed consent.
Ability to provide written informed consent and HIPAA authorization.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Primary tumor of the oropharynx (palatine tonsil, tongue base, soft palate, lateral or posterior walls of oropharynx).
Disqualifiers
Serious medical condition preventing general anesthesia for surgery.
History of previous head and neck radiation or previous head and neck cancer within 3 years.
Distant metastatic disease present.
Subjects with synchronous HPV+ oropharynx primaries
Trial design
Treatments tested in this trial
- NavDx
- Adjuvant Radiation 30 Gray
- Adjuvant Radiation 40 Gray
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov