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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: Active Phase 2 study of Head and Neck Squamous Cell Carcinoma, sponsored by Washington University School of Medicine.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
* Tumor response rate is defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR) based on RECIST criteria * CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). * PR: At least a 30% decrease in the sum of the d
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 |
What the registry record for NCT03389477 still lists
NCT03389477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (78% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03389477's enrollment target sits among peer trials
26 94th of 124 higher than 29 of 124 other Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck 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.
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