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NCT03323463 · ClinicalTrials.gov registry record · Phase 2
Major De-escalation to 30 Gy for Select Human Papillomavirus Associated Oropharyngeal Carcinoma
A Phase 2 study of HPV-Associated Oropharyngeal Squamous Cell Carcinoma and Squamous Cell Carcinoma of the Neck, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 316
- Enrollment target
- 10
- Study locations
NCT03323463: Active Phase 2 study of HPV-Associated Oropharyngeal Squamous Cell Carcinoma and Squamous Cell Carcinoma of the Neck, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03323463 is a Phase 2 study of HPV-Associated Oropharyngeal Squamous Cell Carcinoma and Squamous Cell Carcinoma of the Neck that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 316 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (138% higher). The trial reports 10 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03323463, a Phase 2 study of HPV-Associated Oropharyngeal Squamous Cell Carcinoma and Squamous Cell Carcinoma of the Neck, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 316 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of this study is to demonstrate that participants with HPV positive and hypoxia negative T1-2, N1-2c (AJCC, 7th ed.) oropharyngeal squamous cell carcinoma receiving a major de-escalated radiation therapy with 2 cycles of standard chemotherapy is not inferior to comparable subjects treated with the current standard chemoradiation. Accrual for Cohort A has been completed. Cohort B is active and continues to enroll participants where surgery is optional and proton is allowed.
Primary Outcome
The primary objective of this protocol is to demonstrate that the 2-year locoregional control for this cohort of subjects treated with a major de-escalated radiation dose of 30 Gy is not inferior to comparable subjects treated with the current standard chemoradiation at 70 GY by using a proportion test of patients who demonstrate 2-year locoregional control.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG 5Fluorouracil
- DIAGNOSTIC_TEST F-FMISO PET/CT Scan
- RADIATION 30 Gy over 3 weeks
Study Locations (10)
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Rockville Centre - Rockville Centre
- Memorial Sloan Kettering Nassau - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Monmouth - Middletown
- Memorial Sloan Kettering Bergen - Montvale
Connecticut
- Hartford Healthcare (Data Collection) - Hartford
Florida
- Baptist Alliance MCI (Data Collection Only) - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2017-10-16 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 2 |
What the registry record for NCT03323463 still lists
NCT03323463 is an interventional study that assigns participants to a tested intervention. The registered 316 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (138% higher).
The record links to 2 conditions, with HPV-Associated Oropharyngeal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT03323463 lists 10 locations in 4 states (New York, New Jersey, Connecticut).
Frequently Asked Questions
What is clinical trial NCT03323463 about?
NCT03323463 is a clinical study titled "Major De-escalation to 30 Gy for Select Human Papillomavirus Associated Oropharyngeal Carcinoma". The purpose of this study is to demonstrate that participants with HPV positive and hypoxia negative T1-2, N1-2c (AJCC, 7th ed.) oropharyngeal squamous cell carcinoma receiving a major de-escalated radiation therapy with 2 cycles of standard chemotherapy is not inferior to comparable subjects treate...
What is the current status of trial NCT03323463?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 316 participants. The study started on 2017-10-16. Estimated completion is 2026-10-31.
What conditions does trial NCT03323463 study?
This clinical trial studies the following conditions: HPV-Associated Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Neck.
What interventions are being tested in trial NCT03323463?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), 5Fluorouracil (DRUG), F-FMISO PET/CT Scan (DIAGNOSTIC_TEST), 30 Gy over 3 weeks (RADIATION).
Who is sponsoring clinical trial NCT03323463?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03323463 being conducted?
This trial has 10 study locations across Connecticut, Florida, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03323463's enrollment target sits among peer trials
316 155th of 2000 higher than 1,844 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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