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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 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.
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.
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, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 126-participant average among 26 other Oropharynx Cancer trials with a reported enrollment target (19% higher). The listed sponsor is Nebraska Methodist Health System, which has 5 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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