De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma
1 other identifier
observational
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 6, 2018
CompletedFirst Submitted
Initial submission to the registry
November 11, 2020
CompletedFirst Posted
Study publicly available on registry
November 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2030
ExpectedNovember 9, 2023
April 1, 2023
6.4 years
November 11, 2020
November 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall survival
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
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 Outcomes (3)
Rate of Patients with a Grade 3 or Higher Adverse Event
From randomization to death, assessed up to 10 years
Measure the quality of life of participants using the FACT H&N assessment tool
From randomization to death, assessed up to 10 years
Measure the depression of participants using the Self-Report Quick Inventory of Depressive Symptomatology assessment
From randomization to death, assessed up to 10 years
Study Arms (4)
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.
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.
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
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
Interventions
Transoral resection with neck dissection
6 Cycles of 40 mg/m2
7 Cycles of 40 mg/m2
60 Gy/6 weeks - 2 Gy/fraction, 5 fractions/week
70 Gy/7 weeks - 2 Gy/fraction, 5 fractions/week
Eligibility 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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Related Publications (1)
Panwar A, Shah S, Reid AE, Lydiatt W, Holcomb AJ, Osmolak A, Coughlin A, Militsakh O, Su YB, Mirmiran A, Huang TS, Nolan N, Duckert R, Barney C, Chiu M, Nguyen C, Sayles H, Ganti AK, Lindau R. Quality of Life and Depression Symptoms After Therapy De-Escalation in HPV+ Oropharyngeal Squamous Cell Carcinoma: A Nonrandomized Controlled Trial. JAMA Otolaryngol Head Neck Surg. 2024 May 1;150(5):429-435. doi: 10.1001/jamaoto.2024.0262.
PMID: 38573597DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2020
First Posted
November 20, 2020
Study Start
August 6, 2018
Primary Completion
January 1, 2025
Study Completion (Estimated)
January 1, 2030
Last Updated
November 9, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share