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Adjuvant Treatment Deintensification After Transoral Surgery for Human Papillomavirus-Positive Squamous Cell Carcinoma

NCT05119036 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2026-05-22

No results posted yet for this study

Summary

Oropharyngeal squamous cell carcinoma (OPSCC), commonly known as throat cancer or tonsil cancer, has seen a dramatic rise in incidence over the last twenty years. There are two types of OPSCC: human papillomavirus-positive (HPV+) and human papillomavirus-negative (HPV-). People with OPSCC, regardless of their type, typically receive standard treatment with a combination of chemotherapy, radiation therapy, and surgery. Due to the intensity of standard treatment, survivors may experience unwanted long-term side effects. The goal of this research study is to see if intensifying (stopping or scaling back) treatment still provides the same, or perhaps even better, results when compared to standard treatment.

Conditions

  • Squamous Cell Carcinoma of the Oropharynx
  • HPV Positive Oropharyngeal Squamous Cell Carcinoma

Interventions

RADIATION

44 doses of radiation

Patients will receive 44 gray in 22 fractions to the operative bed, including the primary tumor site and dissected nodal basin. Patients will receive 40 gray in 22 fractions to undissected areas of the neck at low-risk for occult disease.

RADIATION

54 doses of radiation

Patients will receive 54 gray in 27 fractions to the operative bed, including the primary tumor site and dissected nodal basin. Patients will receive 50 gray in 27 fractions to undissected areas of the neck at low-risk for occult disease.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Michael Sim, MD · Indiana University School of Medicine, Indiana University Simon Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05119036 on ClinicalTrials.gov