Clinical trial · Observational
De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma
De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma Based On The AJCC 8th Edition Staging Manual
NCT04638465CI-TRIAL-00071196active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage | HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma by AJCC v8 Clinical Stage | ONTOLOGY_EXACT | 0.98 |
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
Design
Arms and outcomes
Arms (4)
- label
- A - Surgery Only
- description
- 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.
- interventionNames
- Procedure: Transoral robotic surgery
- label
- B - Surgery with Adjuvant Therapy
- description
- 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.
- interventionNames
- Procedure: Transoral robotic surgery
- Drug: Cisplatin - Dose Level 1
- label
- C - Concurrent Chemo/Radiation Therapy - Dose Level 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDPanwar 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 38573597