CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Cetuximabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03769311
NCT03769311Phase 2Completed
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A Window of Opportunity Trial of Cetuximab in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)

University of Wisconsin, Madison·interventional·Posted Dec 7, 2018·Updated May 24, 2023

In Brief

A Phase 2 clinical trial evaluating Cetuximab for Head and Neck Cancer and Squamous Cell Carcinoma. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer, Squamous Cell Carcinoma
CountriesUnited States
CollaboratorsNational Institute of Dental and Craniofacial Research (NIDCR), American Cancer Society, Inc.

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 7, 2018
Enrollment StartApr 17, 2019
Primary CompletionMar 15, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.6 years ago

Interventions

Cetuximabdrug

Monoclonal antibody against epidermal growth factor receptor (EGFR)