HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage, Oropharynx Cancer
Conditions
Keywords
HPV-Mediated, Oropharyngeal Cancer, P16-Positive
Brief 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.
Interventions
PROCEDURETransoral robotic surgery
Transoral resection with neck dissection
DRUGCisplatin - Dose Level 1
6 Cycles of 40 mg/m2
DRUGCisplatin - Dose Level 2
7 Cycles of 40 mg/m2
RADIATIONDose Level 1
60 Gy/6 weeks - 2 Gy/fraction, 5 fractions/week
RADIATIONDose Level 2
70 Gy/7 weeks - 2 Gy/fraction, 5 fractions/week
Sponsors
Nebraska Methodist Health System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival | 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. |
| Overall survival | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Patients with a Grade 3 or Higher Adverse Event | From randomization to death, assessed up to 10 years | To evaluate the side effects patients experience when being treated on the de-escalated protocol. |
| Measure the quality of life of participants using the FACT H&N assessment tool | 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. |
| Measure the depression of participants using the Self-Report Quick Inventory of Depressive Symptomatology assessment | From randomization to death, assessed up to 10 years | To evaluate depression in patients who are treated with the de-escalated protocol. |
Countries
United States
Outcome results
None listed