Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05388773
PHASE2

Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer

Sponsor: Heath Skinner

View on ClinicalTrials.gov

Summary

This is a trial studying patients with human papilloma virus (HPV) positive oropharyngeal cancer with tumors that can be removed via transoral surgery. Following surgery, patients will be classified as either low, intermediate, or high risk based on the characteristics of the tumors. Low risk patients (Arm S) will receive no further treatment after surgery. Intermediate risk patients (Arm RT) will be treated with Intensity Modulated Radiotherapy (IMRT) after surgery. High risk patients (Arm CRT) will receive a combination of IMRT and chemotherapy after surgery. Patients will be followed for up to five years after the completion of treatment.

Official title: Phase II Trial of Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2022-07-20

Completion Date

2030-12-31

Last Updated

2025-06-19

Healthy Volunteers

No

Interventions

PROCEDURE

therapeutic conventional surgery

Transoral surgical resection of tumor(s).

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

quality-of-life assessment

Ancillary studies.

RADIATION

intensity-modulated radiation therapy

Low-dose IMRT

DRUG

Cisplatin

Given IV.

DRUG

Carboplatin

Given IV

Locations (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States