Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04638465 · ClinicalTrials.gov registry record
De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma
A clinical trial of Oropharynx Cancer and HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage, sponsored by Nebraska Methodist Health System.
- Active
- Registry status
- 150
- Enrollment target
- 1
- Study location
NCT04638465: Active study of Oropharynx Cancer and HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage, sponsored by Nebraska Methodist Health System.
NCT04638465 is a study of Oropharynx Cancer and HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage that is active but no longer recruiting, run by Nebraska Methodist Health System. The registered enrollment target is 150 participants, above the 126-participant average among 26 other Oropharynx Cancer trials with a reported enrollment target (19% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04638465, a study of Oropharynx Cancer and HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage, is active but no longer recruiting, sponsored by Nebraska Methodist Health System.
- ACTIVE NOT RECRUITING
- Registry status
- 150 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
To determine if overall survival remains the same with the de-escalated protocol as the historical standard of care survival benefit.
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 |
What the registry record for NCT04638465 still lists
NCT04638465 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 126-participant average among 26 other Oropharynx Cancer trials with a reported enrollment target (19% higher).
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.
NCT04638465 reports a single indexed study location in Nebraska.
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.
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).
Who is sponsoring clinical trial NCT04638465?
This trial is sponsored by Nebraska Methodist Health System, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Oropharynx Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04638465's enrollment target sits among peer trials
150 3rd of 26 higher than 23 of 26 other Oropharynx Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oropharynx Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC)
RECRUITING · Phase 2
-
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
RECRUITING · Phase 2
-
Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)
RECRUITING · Phase 2
-
Neoadjuvant Immunoradiotherapy With Evorpacept and Pembrolizumab in HPVOPC (Human Papilloma Virus Oropharynx Cancer)
RECRUITING · Phase 2
-
Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer
RECRUITING · Phase 2
-
Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00412594 · 150 participants · Phase 2
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
- NCT01484730 · 150 participants
A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion
- NCT01985919 · 150 participants
Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples
- NCT02016248 · 150 participants · NA
SBRT Boost for Unfavorable Prostate Cancer'
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI