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Completed PHASE2 INTERVENTIONAL NCT01412229

Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged appropriate for non-surgical definitive therapy.

Detailed Description

This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged appropriate for non-surgical definitive therapy. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 with good organ function and will be treated with six weekly cycles of carboplatin, nab-paclitaxel and cetuximab prior to scheduled concomitant chemoradiation. The study is designed to evaluate whether this induction regimen can result in an improved response rate (complete response (CR) + partial response (PR)) with less toxicity than the current standard induction docetaxel, cisplatin and 5-fluorouracil (TPF) regimen.

Interventions

Name: Cetuximab
Type: DRUG
Description: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
Name: Nab-paclitaxel
Type: DRUG
Description: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
Name: Carboplatin
Type: DRUG
Description: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.

Primary Outcomes

Measure: Clinical Response Rate Following Induction Chemotherapy
TimeFrame: 9 weeks
Description: Evaluation of target lesions via imaging with CT or MRI scans at 2-3 weeks post induction chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.

Trial Information

NCT ID

NCT01412229

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last Updated

December 15, 2025