NCT04638465View on ClinicalTrials.gov

De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma

Active, not recruitingOBSERVATIONAL
Enrollment

150

Participants

Timeline

Start Date

August 6, 2018

Primary Completion Date

January 31, 2025

Study Completion Date

January 31, 2030

Conditions
HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical StageOropharynx Cancer
Interventions
PROCEDURE

Transoral robotic surgery

Transoral resection with neck dissection

DRUG

Cisplatin - Dose Level 1

6 Cycles of 40 mg/m2

DRUG

Cisplatin - Dose Level 2

7 Cycles of 40 mg/m2

RADIATION

Dose Level 1

60 Gy/6 weeks - 2 Gy/fraction, 5 fractions/week

RADIATION

Dose Level 2

70 Gy/7 weeks - 2 Gy/fraction, 5 fractions/week

Trial Locations (1)

68114

Nebraska Methodist Hospital, Omaha

All Listed Sponsors
lead

Nebraska Methodist Health System

OTHER

NCT04638465 - De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma | Biotech Hunter | Biotech Hunter