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

NCT05388773 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-06-19

No results posted yet for this study

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.

Conditions

  • Oropharynx Cancer

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

Sponsors & Collaborators

  • Heath Skinner

    lead OTHER

Principal Investigators

  • Heath Skinner, MD, PhD · UPMC Hillman Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2028-12-31
Completion
2030-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05388773 on ClinicalTrials.gov