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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 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. The trial reports 10 study locations across 4 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03323463
The ClinicalTrials.gov registry entry for NCT03323463 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 316 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
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 reports 10 study locations spanning 4 distinct geographic areas - top geographies include 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.
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