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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 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 96 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02573493
The ClinicalTrials.gov registry entry for NCT02573493 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT02573493 reports 0 study locations.
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.
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