Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Florida
About this trial
This study builds on the results of several prior studies that we have been involved with to test the hypothesis that Risk-Adapted De-Intensification of Radiation Therapy and chemotherapy based on HPV subtype, plasma circulating free HPV DNA (cfHPV DNA) level, and cfHPV DNA clearance rate produces Local-Regional Control rates that are similar to what has been achieved with more aggressive therapy in patients with Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma (OPSCC).
Eligibility criteria
Qualifiers
≥ 18 years of age (no upper age limit)
T0-3, N0 to N2, M0 squamous cell carcinoma of the oropharynx by AJCC 8th Edition staging. If T0 the adenopathy must be predominantly in Level 2.
Tissue diagnosis of HPV and/or p16 positivity from the primary site or an associated lymph node.
Radiologic confirmation of the absence of lung metastasis within 12 weeks prior to treatment; at a minimum, CT of the chest is required. PET-CT is acceptable.
Disqualifiers
Prior radiotherapy for oropharyngeal squamous cell carcinoma (OPSCC) OR to the head and neck that, if combined with the protocol therapy, is deemed likely to compromise critical organs at risk in the opinion of the investigator.
Prior cancer within the last 10 years.
Prior surgery with curative intent for this OPSCC.
Patients who have undergone tonsillectomy for diagnosis or excisional biopsy of a neck node for diagnosis are eligible provided there is "gross" cancer present at the primary site or in the neck at the start of radiation therapy on this protocol with "gross" defined as visible on an imaging study.
Trial design
Treatments tested in this trial
- Radiation therapy
- Cisplatin
Treatment groups
250 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Florida
Lead sponsor
Naveris, Inc.
Collaborator
Source ClinicalTrials.gov