De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma

November 7, 2023 updated by: Nebraska Methodist Health System

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Brianna Conyers
  • Phone Number: 402-354-5162

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A - Surgery Only

Participants with the following diagnosis will receive transoral robotic surgery with neck dissection:

  • Base of Tongue/Non-Tonsil Oropharynx - Stage: cT1-2, cN0 or N1 (single node)
  • Tonsil - Stage: cT1-3, cN0 or N1 (single node)
  • Unknown primary - Stage: cT0 N1 (single node)

Radiation also given if indicated by intermediate or high risk features following surgery.
Procedure: Transoral robotic surgery
Transoral resection with neck dissection
B - Surgery with Adjuvant Therapy

Participants with the following diagnosis will receive surgery followed by 6 Cycles of Cisplatin 40 mg/m2:

  • Base of Tongue/Non-Tonsil Oropharynx - Stage: cT1-2, cN1 (2-4 nodes) or N2
  • Tonsil - Stage: cT1-3, N1 (2-4 nodes)

Radiation also given if indicated by intermediate or high risk features following surgery.
Procedure: Transoral robotic surgery
Transoral resection with neck dissection
Drug: Cisplatin - Dose Level 1
6 Cycles of 40 mg/m2
C - Concurrent Chemo/Radiation Therapy - Dose Level 1

Participants with the following diagnosis will receive 6 Cycles of Cisplatin 40 mg/m2 + 60 Gy Radiation:

  • Tonsil - Stage: cT1-3, N2
  • Unknown Primary - Stage: cT0, N2
Drug: Cisplatin - Dose Level 1
6 Cycles of 40 mg/m2
Radiation: Dose Level 1
60 Gy/6 weeks - 2 Gy/fraction, 5 fractions/week
D - Concurrent Chemo/Radiation Therapy - Dose Level 2

Participants with the following diagnosis will receive 7 Cycles of Cisplatin 40 mg/m2 + 70 Gy Radiation:

  • Base of Tongue/Non-Tonsil Oropharynx - Stage: cT3-4, any N
  • Base of Tongue/Non-Tonsil Oropharynx - Stage: cAny T, N3
  • Tonsil - Stage: cT1-3, N3
  • Tonsil - Stage: cT4, any N
  • Unknown Primary - Stage: cT0, N3
Drug: Cisplatin - Dose Level 2
7 Cycles of 40 mg/m2
Radiation: Dose Level 2
70 Gy/7 weeks - 2 Gy/fraction, 5 fractions/week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomization to death, assessed up to 10 years
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.
From randomization to date of progression, second primary tumor from the head and neck region, or death, assessed up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomization to death, assessed up to 10 years
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.
From randomization to death, assessed up to 10 years
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.
From randomization to death, assessed up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nebraska Methodist Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2018

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

November 11, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 20, 2020

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MECC-HN01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oropharynx Cancer

Clinical Trials on Transoral robotic surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe