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NCT02573493 · ClinicalTrials.gov registry record · Phase 2
Nab-Paclitaxel and Cisplatin or Nab-paclitaxel as Induction Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC)
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
NCT02573493: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT02573493 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 96 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02573493, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
Study Summary
In this trial, the objectives are to determine the efficacy and toxicity of induction chemotherapy (IC) with nab-paclitaxel + cisplatin (Arm 1: AP) and with nab-paclitaxel (Arm 2: A) alone in patients with HNSCC, and to compare these data to nab-paclitaxel, cisplatin, and 5-FU (APF). The investigators also hypothesize that the high anti-tumor efficacy of nab-paclitaxel in HNSCC is due to the upregulation of macropinocytosis, a result of the frequent presence of Ras and PI3K (and epidermal growth factor receptor -EGFR) activation in this cancer. Amendment to Add Arm 3: In this amendment, the investigators retain the AP + concurrent chemoradiation therapy (CRT) backbone but de-escalate the dose of radiation therapy (RT) from 70 Gy to 42 Gy. The investigators also plan to administer one dose (vs three) of cisplatin during RT. This novel treatment approach will be evaluated in patients with HPV-related oropharyngeal squamous cell carcinoma (OPSCC) (Arm 3), a sub-group with a very favorable prognosis.
Primary Outcome
* Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ear, nose, and throat (ENT) physician's clinical exam note. * Complete response = complete resolution - 100% decrease/minimal residual mucosal abnormality
Interventions
- DRUG Cisplatin
- BIOLOGICAL Cetuximab
- RADIATION Intensity-Modulated Radiation Therapy
- DRUG nab-Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2016-04-13 |
| Est. Completion | 2024-07-01 |
| Phase | Phase 2 |
What the finished NCT02573493 record still lists
NCT02573493 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT02573493 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02573493 about?
NCT02573493 is a clinical study titled "Nab-Paclitaxel and Cisplatin or Nab-paclitaxel as Induction Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC)". In this trial, the objectives are to determine the efficacy and toxicity of induction chemotherapy (IC) with nab-paclitaxel + cisplatin (Arm 1: AP) and with nab-paclitaxel (Arm 2: A) alone in patients with HNSCC, and to compare these data to nab-paclitaxel, cisplatin, and 5-FU (APF). The investigato...
What is the current status of trial NCT02573493?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2016-04-13. Estimated completion is 2024-07-01.
What interventions are being tested in trial NCT02573493?
The interventions under investigation include: Cisplatin (DRUG), Cetuximab (BIOLOGICAL), Intensity-Modulated Radiation Therapy (RADIATION), nab-Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT02573493?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02573493's enrollment target sits among peer trials
96 747th of 2000 higher than 1,242 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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