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De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma
NCT04638465 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- PROCEDURE Transoral robotic surgery
- DRUG Cisplatin - Dose Level 1
- DRUG Cisplatin - Dose Level 2
- RADIATION Dose Level 1
- RADIATION Dose Level 2
Study Locations (1)
Nebraska
- Nebraska Methodist Hospital — Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2018-08-06 |
| Est. Completion | 2030-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04638465
The ClinicalTrials.gov registry entry for NCT04638465 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nebraska Methodist Health System, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Oropharynx Cancer appearing as the primary indexed condition, and to 5 interventions — of which Transoral robotic surgery is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04638465 reports 1 study location spanning 1 distinct geographic area — top geographies include Nebraska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04638465 about?
NCT04638465 is a clinical study titled "De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma". 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...
What is the current status of trial NCT04638465?
This trial is currently active not recruiting. The enrollment target is 150 participants. The study started on 2018-08-06. Estimated completion is 2030-01.
What conditions does trial NCT04638465 study?
This clinical trial studies the following conditions: Oropharynx Cancer, HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04638465?
The interventions under investigation include: Transoral robotic surgery (PROCEDURE), Cisplatin - Dose Level 1 (DRUG), Cisplatin - Dose Level 2 (DRUG), Dose Level 1 (RADIATION), Dose Level 2 (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04638465?
This trial is sponsored by Nebraska Methodist Health System, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04638465 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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