Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer

This is a trial studying patients with human papilloma virus (HPV) positive oropharyngeal cancer with tumors that can be removed via transoral surgery. Following surgery, patients will be classified as either low, intermediate, or high risk based on the characteristics of the tumors. Low risk patients (Arm S) will receive no further treatment after surgery. Intermediate risk patients (Arm RT) will be treated with Intensity Modulated Radiotherapy (IMRT) after surgery. High risk patients (Arm CRT) will receive a combination of IMRT and chemotherapy after surgery. Patients will be followed for up

Trial Details

NCT ID
NCT05388773
Phase
PHASE2
Sponsor
Heath Skinner
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • therapeutic conventional surgery
  • laboratory biomarker analysis
  • quality-of-life assessment
  • intensity-modulated radiation therapy
  • Cisplatin
  • Carboplatin
Locations (sample)
  • Pittsburgh, Pennsylvania, United States|40.44062,-79.99589

Key Eligibility Criteria

  • ECOG performance status of 0 or 1 or Karnofsky score 80-100.
  • Preference is to register patients prior to surgery. However, if not registered prior to surgery, the patient can be registered prior to adjuvant t…
  • Patients must have newly diagnosed, histologically or cytologically confirmed SCC or undifferentiated carcinoma of the oropharynx. Patients must ha…
  • Patients must be deemed eligible for a TOS procedure with no evidence of distant metastasis as determined by imaging studies. Metastatic disease ma…

For full eligibility, visit ClinicalTrials.gov.

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