P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC

Completed · Phase 2

Conditions studied: Carcinoma, Squamous Cell, Head and Neck Neoplasms, Oropharyngeal Neoplasms

In brief

The primary objective of this study is to evaluate whether genomic based risk-stratification can be used in deciding whether to de-intensify in patients with Human Papillomavirus (HPV)-associated Oropharyngeal Squamous Cell Carcinoma (OPSCC) with \> 10 pack years smoking history. Hypothesis: Patients with HPV-associated OPSCC, \> 10 pack years smoking history, and non-mutated p53 will have similar 2 year progression-free survival (PFS) as patients with \< 10 pack years smoking history.

Key facts

Study ID

NCT03077243

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

195

Starts

2016-12-01

Expected to finish

2022-12-14

Last updated by the study team

2024-05-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age (no upper age limit)
• T0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynx
• Biopsy proven squamous cell carcinoma that is HPV and/or p16 positive
• Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to treatment
• ECOG Performance Status 0-1
• CBC/differential obtained within 8 weeks prior to treatment, with adequate bone marrow function defined as follows: Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl
• Adequate renal and hepatic function within 4 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
• Negative pregnancy test within 2 weeks prior to treatment for women of childbearing potential
• Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment.
• Patients must be deemed able to comply with the treatment plan and follow-up schedule.
• Patients must provide study specific informed consent prior to study entry

You may not qualify if…

• Prior history of radiation therapy to the head and neck
• Prior history of head and neck cancer.
• Unresectable disease (e.g. immobile node on physical exam, nodal disease that radiographically involves the carotid arteries, nerves)
• Currently taking Disease Modifying Rheumatoid Drugs (DMRDs)
• Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; Transmural myocardial infarction within the last 6 months; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (Note, however, coagulation parameters are not required for entry into this protocol); Pre-existing ≥ grade 2 neuropathy; Prior organ transplant; Systemic lupus; Psoriatic arthritis
• Known HIV positive.

Where it is running

• University of Florida — Gainesville, Florida, United States
• University of Florida Proton Therapy Institute — Jacksonville, Florida, United States
• University of North Carolina at Chapel Hill, Department of Radiation Oncology — Chapel Hill, North Carolina, United States
• Rex Healthcare — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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