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Induction Chemo Then Concurrent Chemoradiotherapy With Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer

NCT01326923 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-10-09

Study results available
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Summary

This is an open label, single arm Phase II study of induction chemotherapy followed by concurrent chemo-radiotherapy in patients with locally advanced head and neck squamous cell cancer (HNSCC) using monoclonal antibody cetuximab. Those patients with locally advanced HNSCC deemed to be candidates for definitive concurrent chemo-radiotherapy will be treated initially with 6 weeks of PCC (Paclitaxel, cetuximab and Carboplatin). This will be followed by a week of no treatment for interim evaluation, followed by definitive concurrent chemo-radiotherapy using 70Gy radiation with weekly cetuximab and cisplatin for 7 weeks. The hypothesis of the study is that the use of cetuximab during induction chemotherapy followed by cetuximab concurrent with chemoradiotherapy using low dose weekly cisplatin will improve local control as well as distant spread.

Conditions

  • Head and Neck Squamous Cell Cancer

Interventions

DRUG

Cetuximab

Single arm phase II study of chemotherapy

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center Shreveport

    lead OTHER

Principal Investigators

  • Syed H Jafri, MB,B,S · LSU shreveport

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01326923 on ClinicalTrials.gov