P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC (NCT03077243) | Clinical Trial Compass
CompletedPhase 2
P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC
United States195 participantsStarted 2016-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥ 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
Exclusion criteria
✕. 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)
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: Two years after completion of the treatment
. 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