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NCT03769311 · ClinicalTrials.gov registry record · Phase 2
Cetuximab in Head and Neck Cancer Patients
A Phase 2 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT03769311: Completed Phase 2 study, sponsored by University of Wisconsin, Madison.
NCT03769311 is a Phase 2 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03769311, a Phase 2 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This clinical trial is for participants with head and neck squamous cell carcinoma who are scheduled to have their tumor surgically removed. The study involves obtaining baseline tissue from a clinical biopsy or research biopsy and measurement of circulating tumor cells before surgery to determine whether AXL protein expression pre-treatment correlates to clinical outcomes (change in tumor size) after two doses of cetuximab. The importance of this study is to describe if AXL expression can be used as a biomarker to predict clinical response to cetuximab (CTX) treatment.
Primary Outcome
The tumor size (via clinical measurements) will be measured from the time of diagnosis (pre-CTX) to after treatment with 2 doses of cetuximab and within 48 hours prior to surgery (post-CTX). Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Committee criteria will be used to define clinical response (partial response, progressive disease, or stable disease) prior to surgery.
Interventions
- DRUG Cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-04-17 |
| Est. Completion | 2022-03-15 |
| Phase | Phase 2 |
What the finished NCT03769311 record still lists
NCT03769311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Cetuximab is the first listed.
NCT03769311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03769311 about?
NCT03769311 is a clinical study titled "Cetuximab in Head and Neck Cancer Patients". This clinical trial is for participants with head and neck squamous cell carcinoma who are scheduled to have their tumor surgically removed. The study involves obtaining baseline tissue from a clinical biopsy or research biopsy and measurement of circulating tumor cells before surgery to determine w...
What is the current status of trial NCT03769311?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2019-04-17. Estimated completion is 2022-03-15.
What interventions are being tested in trial NCT03769311?
The interventions under investigation include: Cetuximab (DRUG).
Who is sponsoring clinical trial NCT03769311?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03769311's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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