drugset / Trial / NCT03077243
P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |