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NCT03389477 · ClinicalTrials.gov registry record · Phase 2
Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma
A Phase 2 study of Head and Neck Squamous Cell Carcinoma, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT03389477 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 26 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03389477, a Phase 2 study of Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the results of treating patients with HPV-unrelated head and neck squamous cell carcinoma with neoadjuvant single-agent palbociclib, followed by chemoradiation (either cisplatin + IMRT or cetuximab + IMRT depending on patient characteristics), followed by adjuvant single-agent palbociclib.
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Cetuximab
- DRUG Palbociclib
- RADIATION Intensity-Modulated Radiation Therapy
- PROCEDURE Tumor biopsy
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2018-04-27 |
| Est. Completion | 2027-04-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03389477
The ClinicalTrials.gov registry entry for NCT03389477 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (78% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT03389477 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT03389477 about?
NCT03389477 is a clinical study titled "Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma". The purpose of this study is to evaluate the results of treating patients with HPV-unrelated head and neck squamous cell carcinoma with neoadjuvant single-agent palbociclib, followed by chemoradiation (either cisplatin + IMRT or cetuximab + IMRT depending on patient characteristics), followed by adj...
What is the current status of trial NCT03389477?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2018-04-27. Estimated completion is 2027-04-06.
What conditions does trial NCT03389477 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT03389477?
The interventions under investigation include: Cisplatin (DRUG), Cetuximab (DRUG), Palbociclib (DRUG), Intensity-Modulated Radiation Therapy (RADIATION), Tumor biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT03389477?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03389477 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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