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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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