OncoMatch/Clinical Trials/NCT05268614
Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma
Is NCT05268614 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cisplatin for oropharyngeal squamous cell carcinoma.
Treatment: Cisplatin — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV positivity
Tissue diagnosis of HPV and/or p16 positivity from the primary site or an associated lymph node.
Required: CDKN2A p16 positivity
Tissue diagnosis of HPV and/or p16 positivity from the primary site or an associated lymph node.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: radiotherapy
Exception: unless prior radiotherapy for oropharyngeal squamous cell carcinoma or to the head and neck is not deemed likely to compromise critical organs at risk in the opinion of the investigator
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.
Cannot have received: surgery with curative intent
Exception: tonsillectomy for diagnosis or excisional biopsy of a neck node for diagnosis are eligible if 'gross' cancer present at the primary site or in the neck at the start of radiation therapy
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.
Lab requirements
Blood counts
Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl (transfusion/intervention allowed to achieve threshold)
Kidney function
Serum creatinine < 2.0 mg/dl
Liver function
Total bilirubin < 2 x the institutional ULN; AST or ALT < 3 x the institutional ULN; physician attestation of no known history of liver disease can substitute for labs.
CBC/differential obtained within 12 weeks prior to treatment, with adequate bone marrow function defined as follows: Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.) Adequate renal and hepatic function within 12 weeks prior to treatment, defined as follows: Serum creatinine < 2.0 mg/dl; Total bilirubin < 2 x the institutional ULN; AST or ALT < 3 x the institutional ULN; Note that physician attestation of patient having no known history of liver disease can take the place of bilirubin and AST/ALT labs.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Florida · Gainesville, Florida
- UF Health Proton Therapy Institute · Jacksonville, Florida
- Medical University of South Carolina · Charleston, South Carolina
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify