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NCT03215719 · ClinicalTrials.gov registry record · Phase 2
Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma
A Phase 2 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Oropharyngeal Carcinoma, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT03215719: Recruiting Phase 2 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Oropharyngeal Carcinoma, sponsored by NYU Langone Health.
NCT03215719 is a Phase 2 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Oropharyngeal Carcinoma that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 120 participants, above the 84-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (43% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03215719, a Phase 2 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Oropharyngeal Carcinoma, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase II clinical trial. The purpose of this study is to determine the feasibility of deescalating chemoradiation treatment based on mid-treatment tumor response determined by rapid nodal shrinkage and clearance of circulating HPV plasma tumor DNA . The primary objective of this study is to evaluate progression-free survival at 2 years.
Primary Outcome
The non-inferiority (NI) analysis will be conducted on the pooled de-escalated cohort (Arms 3+4 combined) to evaluate whether the 2-year PFS is acceptable relative to the historical benchmark. For Arm 3 and Arm 4 separately, Kaplan-Meier curves and 2-year PFS estimates with 95% confidence intervals will be provided. Patients who do not experience progression of disease and have not died will be censored on the date of last follow up.
Conditions Studied
Interventions
- RADIATION Standard Radiation Treatment
- RADIATION Dose-Deescalated Treatment
- DRUG Cisplatinum
Study Locations (1)
New York
- New York University School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2017-10-18 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
What NCT03215719 shows while recruiting
NCT03215719 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 84-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (43% higher).
The record links to 2 conditions, with HPV Positive Oropharyngeal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Standard Radiation Treatment is the first listed.
NCT03215719 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03215719 about?
NCT03215719 is a clinical study titled "Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma". This is a phase II clinical trial. The purpose of this study is to determine the feasibility of deescalating chemoradiation treatment based on mid-treatment tumor response determined by rapid nodal shrinkage and clearance of circulating HPV plasma tumor DNA . The primary objective of this study is t...
What is the current status of trial NCT03215719?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2017-10-18. Estimated completion is 2028-12.
What conditions does trial NCT03215719 study?
This clinical trial studies the following conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Carcinoma.
What interventions are being tested in trial NCT03215719?
The interventions under investigation include: Standard Radiation Treatment (RADIATION), Dose-Deescalated Treatment (RADIATION), Cisplatinum (DRUG).
Who is sponsoring clinical trial NCT03215719?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03215719 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HPV Positive Oropharyngeal Squamous Cell Carcinoma
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 NCT03215719's enrollment target sits among peer trials
120 3rd of 16 higher than 14 of 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HPV Positive Oropharyngeal Squamous Cell Carcinoma 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
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