OncoMatch/Clinical Trials/NCT05388773
Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer
Is NCT05388773 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cisplatin and Carboplatin for oropharynx cancer.
Treatment: Cisplatin · Carboplatin — 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 to five years after the completion of treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A overexpression (p16 positive by IHC)
biopsy-proven p16+ oropharynx cancer; ... positive p16 IHC (as surrogate for HPV) status ... p16 protein expression using immunohistochemistry (IHC) performed by a CLIA approved laboratory
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
Exception: above the clavicles
No prior radiation above the clavicles.
Lab requirements
Kidney function
acceptable renal function within 4 weeks prior to registration; for Arm CRT, calculated creatinine clearance must be > 60 ml/min using Cockcroft-Gault formula
Liver function
acceptable hepatic function within 4 weeks prior to registration
Patients must have acceptable renal and hepatic function within 4 weeks prior to registration. For Arm CRT, calculated creatinine clearance must be > 60 ml/min using the Cockcroft-Gault formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UPMC Hillman Cancer Center · Pittsburgh, Pennsylvania
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