At a glance
ClinicalIndex Comparison Record- ✓Age 18 or older with no upper age limit
- ✓T0-3, N0-N2, M0 oropharyngeal squamous cell carcinoma by AJCC 8th Edition staging; if T0 then adenopathy predominantly Level 2
- ✓HPV and/or p16 positivity from primary site or associated lymph node
- ✓Radiologic confirmation of absence of lung metastasis within 12 weeks; CT chest minimum, PET-CT acceptable
- ✕Prior radiotherapy for oropharyngeal or head/neck cancer that would compromise critical organs
- ✕Prior cancer within last 10 years, except non-oropharynx cancers resolved or with indolent growth rate per treating physician
- ✕Prior surgery with curative intent for this oropharyngeal squamous cell carcinoma
- ✕Inhalation smoking of tobacco within last 10 years with >10 pack-year equivalent history
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Risk Adapted De-Intensification of Radio-Chemotherapy for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma Based on HPV Subtype and Plasma Circulating Free HPV DNA Level and Clearance Rate
In Brief
A Phase 2 clinical trial evaluating Radiation therapy and Cisplatin for Oropharyngeal Squamous Cell Carcinoma. Currently recruiting, targeting 250 participants across 3 sites.
Signals
Detailed Summary
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).
Study Details
Timeline
Interventions
Participants will receive either 70 gray (Gy), 60 Gy, or 50 Gy of radiation based on the following criteria: 70 Gy: Pretreatment level of plasma circulating free HPV DNA (cfHPV DNA) ≤ 3 copies/mL 60 Gy: Tumor tissue positive for HPV subtype other than 16 OR Pretreatment level of cfHPV DNA 4-99 copies/mL OR Pretreatment level of cfHPV DNA ≥ 100 copies/mL AND \<95% decrease in the level cfHPV DNA by the end of week 4 of radiation therapy 50 Gy: Tumor tissue positive for HPV subtype 16, pretreatment level of cfHPV DNA ≥ 100 copies/mL, AND ≥ 95% decrease in the level cfHPV DNA by the end of week 4 of radiation therapy
All participants will receive 40 mg/m2 of cisplatin intravenously over 60 minutes weekly during radiation therapy. If cisplatin is not recommended by the treating medical oncologist or is not tolerated, it is permissible to switch to an alternative chemotherapy regimen per institutional practice, but chemotherapy should not be discontinued unless mandated by the patient's condition.