Phase 2
N=195
P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC
Carcinoma, Squamous Cell · Head and Neck Neoplasms · Oropharyngeal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT03077243 ↗Enrolled (actual)
195
Serious AEs
—
Results posted
May 2024
Primary outcome: Primary: Progression Free Survival (PFS) — 3; 6; 0; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intensity Modulated Radiotherapy (IMRT) (Radiation); Cisplatin (or alternative) (Drug); Assessment for surgical evaluation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
3; 6; 0; 8; 45; 2 | — |
| SECONDARY Number of Participants With Plasma Circulating Free DNA -Baseline |
13; 59; 2; 1; 4; 0 | — |
| SECONDARY Number of Participants With Plasma Circulating Free DNA -3months |
3; 19; 0; 10; 40; 1 | — |
| SECONDARY Number of Participants With Plasma Circulating Free DNA -1 Year |
2; 10; 0; 5; 41; 0 | — |
| SECONDARY Number of Participants With Plasma Circulating Free DNA -2 Year |
2; 16; 0; 4; 23; 1 | — |
| SECONDARY Local Control Rate |
0; 0; 0; 11; 51; 2 | — |
| SECONDARY Regional Control Rate |
1; 2; 0; 10; 49; 2 | — |
| SECONDARY Local-regional Control Rate |
1; 2; 0; 10; 49; 2 | — |
| SECONDARY Distant Metastasis Free Survival |
2; 4; 0; 9; 47; 2 | — |
| SECONDARY Overall Survival Rate |
1; 4; 0; 11; 51; 2 | — |
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.
Eligibility Criteria
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
- 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
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)
- 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.
Data sourced from ClinicalTrials.gov (NCT03077243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.