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De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma

NCT04638465 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-11-09

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effects, good and/or bad, of treating participants with HPV-mediated oropharyngeal cancer, with less treatment, using the new staging system. The investigators believe this treatment will provide the same effectiveness as the usual treatment, but decrease the side effects. The radiation doses, chemotherapy doses, and the type of surgical approaches that will be used in this treatment protocol have all been previously investigated. Previous research suggests that this can be done safely, but there has not been a study done basing treatment on the new staging system.

Conditions

  • HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage
  • Oropharynx 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

Sponsors & Collaborators

  • Nebraska Methodist Health System

    lead OTHER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-06
Primary Completion
2025-01-31
Completion
2030-01-31
FDA Drug
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 NCT04638465 on ClinicalTrials.gov