drugset / Trial / NCT03077243

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

NCT03077243 ↗

Phase 2 Completed 195 enrolled UNC Lineberger Comprehensive Cancer Center
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2016-12
Primary completion
2022-12-14
Completion
2022-12-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 1.5 unknown Intravenous
Subject Carboplatin Small molecule 3 unknown Intravenous
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 30 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 40 mg/m2 Intravenous
Subject Paclitaxel Small molecule 45 mg/m2 Intravenous