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Active, Not Recruiting

NCT Number: NCT04638465

De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage Head and Neck Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Oropharynx Cancer Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have newly diagnosed, histologically, or cytologically confirmed HPV positive, squamous cell carcinoma of the base of tongue, tonsil, oropharyngeal cavity or unknown primary.
  • Participants must have tumors staged using AJCC TNM 8th edition Staging for Head and Neck cancers.
  • Participants must have an exam by a Head and Neck Oncologist within 6 weeks before registration.
  • Participants must not have any evidence of distant metastatic disease.
  • Participants with other active malignancies may be eligible, at the discretion of the investigator, as long as the treatment plan for the head and neck cancer outlined in this protocol can still be followed. The potential effect of the treatment and disease progress of the second active malignancy should also have minimal or no impact on the toxicities being monitored on this study.
  • Participants must not have any uncontrolled intercurrent illnesses, psychiatric illnesses, psychosocial problems, or social situations that would limit the patient's compliance with the study or ability to successfully complete the study treatment safely.
  • Participants with inconclusive pathology after biopsy; who are found to have HPV positive SCC following standard of care surgery are eligible to enroll.
  • Participants who require additional surgery to complete staging with known HPV+ SCC are eligible to enroll.

Exclusion criteria

  • Participants must not be receiving or planning to receive any other clinical trial therapy or intervention.
  • Participants with an unknown primary tumor who are both HPV positive and EBV positive are NOT eligible for this protocol.

These additional evaluations must be performed on participants with T0 (unknown primary site) P16+ squamous cell carcinoma of the head and neck prior to registration.

  • Flexible laryngoscope
  • Ultrasound guided Fine-needle aspirate (FNA) of the known site of disease with the following analysis:
  • Human papilloma virus (HPV); p16 Immuno-Histo-Chemical Staining. If negative, complete high risk HPV Fluorescence in-situ Hybridization (FISH).
  • Epstein Barr Virus (EBV): Epstein Barr Virus Encoded RNA (EBER) in-situ Hybridization.
  • Direct Laryngoscopy with directed biopsy of bilateral base of tongue, bilateral palatine tonsillectomy, and dental extraction, as needed.

If a participant is both HPV positive and EBV positive, he/she is not eligible.

Treatment and study plan

Transoral Robotic Surgery

Procedure

Transoral resection with neck dissection

Cisplatin - Dose Level 1

Drug

6 Cycles of 40 mg/m2

Cisplatin - Dose Level 2

Drug

7 Cycles of 40 mg/m2

Dose Level 1

Radiation

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

Dose Level 2

Radiation

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

Primary outcomes

  1. Overall survival

    Time frame: From randomization to death, assessed up to 10 years

    To determine if overall survival remains the same with the de-escalated protocol as the historical standard of care survival benefit.

  2. Disease Free Survival

    Time frame: From randomization to date of progression, second primary tumor from the head and neck region, or death, assessed up to 10 years

    To determine if disease free survival remains the same with the de-escalated protocol as the historical standard of care survival benefit.

Secondary outcomes

  1. Rate of Patients with a Grade 3 or Higher Adverse Event

    Time frame: From randomization to death, assessed up to 10 years

    To evaluate the side effects patients experience when being treated on the de-escalated protocol.

  2. Measure the quality of life of participants using the FACT H&N assessment tool

    Time frame: From randomization to death, assessed up to 10 years

    To evaluate the quality of life of patients who are treated with the de-escalated protocol.

  3. Measure the depression of participants using the Self-Report Quick Inventory of Depressive Symptomatology assessment

    Time frame: From randomization to death, assessed up to 10 years

    To evaluate depression in patients who are treated with the de-escalated protocol.

Sponsors and collaborators

Lead sponsor

Nebraska Methodist Health System

Other

Registry information

Official study title

De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma Based On The AJCC 8th Edition Staging Manual

Important dates

Study start
2018
Primary completion
2025
Study completion
2030
First posted
Nov 20, 2020
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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