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ACTIVE NOT RECRUITING Phase 2

Major De-escalation to 30 Gy for Select Human Papillomavirus Associated Oropharyngeal Carcinoma

NCT03323463 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 316 participants
Start Date 2017-10-16
Est. Completion 2026-10-31
Phase Phase 2

Sponsor

Memorial Sloan Kettering Cancer Center

2,280 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 2,280 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03323463 reports 10 study locations spanning 4 distinct geographic areas — top geographies include New York, New Jersey, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03323463?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 2,280 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial