OncoMatch/Clinical Trials/NCT06445114
Using CircuLating Tumor DNA to Risk Adapt Post-Operative Therapy for HPV-associated Oropharyngeal Cancer
Is NCT06445114 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cisplatin for oropharyngeal cancer.
Treatment: Cisplatin — This is a single institution phase II study that will enroll patients with T0-3N0-2 p16-positive oropharyngeal squamous cell carcinoma (OSCC) undergoing resection of all gross visible disease at the primary site and in the lymph nodes.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A strongly positive by immunohistochemistry (strongly positive)
p16 is strongly positive by immunohistochemistry
Required: HPV high-risk HPV detected by in-situ hybridization
high-risk HPV is detected by in-situ hybridization
Required: HPV detectable cTTMV-HPV DNA (detectable)
detectable cTTMV-HPV DNA based on pre-operative NavDx testing...NavDx testing should be performed on the tumor tissue to ensure detectable HPV DNA and for HPV subtyping
Disease stage
Excluded: Stage PT4, CN3
AJCC 8th edition T0-3N0-2 p16-positive oropharyngeal... Exclusion: AJCC 8th edition pT4 or cN3 disease.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: surgery — gross total resection of all known disease in the head and neck via transoral robotic surgery or non-robotic surgery
Have undergone or will undergo gross total resection of all known disease in the head and neck via transoral robotic surgery...If the primary tumor is resected with negative margins with a non-robotic surgery, such as a diagnostic tonsillectomy, this is considered acceptable and further robotic surgery is not necessary.
Must have received: neck dissection
Have undergone or will undergo neck dissection.
Cannot have received: radiation therapy
Exception: prior radiation to the head and neck ≤ 30 Gy allowed
Prior radiation to the head and neck > 30 Gy
Cannot have received: cisplatin (cisplatin)
Prior allergic reaction to cisplatin
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; Platelets ≥ 100,000 cells/mm3; ANC ≥ 1.5 x 10^9/L
Kidney function
Serum creatinine ≤1.5 x ULN OR creatinine clearance ≥50 mL/min (Cockcroft-Gault equation)
Liver function
Total bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 3.0 x ULN
Adequate hematologic and renal function within 56 days of start of chemoradiation, defined as: Hemoglobin ≥ 9.0 g/dL; Platelets ≥ 100,000 cells/mm3; ANC ≥ 1.5 X 10^9/L; Total bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 3.0 x ULN; Serum creatinine ≤1.5 x ULN OR a calculated creatinine clearance ≥50 mL/min estimated using the Cockcroft-Gault equation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cedars-Sinai Cancer at Beverly Hills (THO) · Beverly Hills, California
- Cedars Sinai Medical Center · Los Angeles, California
- CS Cancer at Valley Oncology Medical Group · Tarzana, California
- CS Cancer at the Hunt Cancer Center · Torrance, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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