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Cetuximab for Head and Neck Cancers

Phase 2
Waitlist Available
Led By Vinita Takiar, MD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically (histologically) proven diagnosis of cutaneous squamous cell carcinoma of the head and neck
Clinical stage >/= T3 or >/= N1, M0 including no distant metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is studying cetuximab combined with radiation therapy in treating patients with cutaneous head and neck cancer.

Eligible Conditions
  • Head and Neck Cancers

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Local Regional Control
Secondary outcome measures
Percentage of Participants With Disease-free Survival
Percentage of Participants With Overall Survival

Side effects data

From 2012 Phase 3 trial • 73 Patients • NCT01177956
43%
Leucopenia
43%
Weight Decreased
40%
Nausea
35%
Rash
34%
Hypomagnesaemia
32%
Hypokalemia
31%
Constipation
28%
Neutropenia
28%
Vomiting
26%
Decreased Appetite
22%
Pyrexia
19%
Acne
19%
Hyponatremia
19%
Hemoglobin Decreased
18%
Stomatitis
18%
Diarrhea
15%
Fatigue
15%
Pruritus
13%
Mucosal Inflammation
13%
Neutrophil Count Decreased
12%
Mouth Ulceration
10%
Insomnia
10%
Thrombocytopenia
10%
Asthenia
9%
Dizziness
9%
Cough
9%
White Blood Cell Count Decreased
7%
Hypochloremia
7%
Hypocalcaemia
7%
Dermatitis Acneiform
7%
Abdominal Pain Upper
7%
Paronychia
7%
Aspartate Aminotransferase Increased
7%
Weight Increased
6%
Neck pain
6%
Dyspnoea
6%
Oral Pain
6%
Headache
3%
Anaphylactic reaction
1%
Pulmonary embolism
1%
Staphylococcal skin infection
1%
Tumor hemorrhage
1%
Electrolyte imbalance
1%
Pneumonitis
1%
Microcytic anemia
1%
Mouth hemorrhage
1%
Respiratory alkalosis
1%
Myocardial infarction
1%
Pneumonia
1%
Toxic encephalopathy
1%
Venous thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase
Cetuximab + Cisplatin + 5-FU : Late Phase

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cetuximab and RadiationExperimental Treatment2 Interventions
Cetuximab 400 mg/m2 IV over 120 minutes loading dose > 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
427 Previous Clinical Trials
634,347 Total Patients Enrolled
Vinita Takiar, MDPrincipal InvestigatorUniversity of Cincinnati
1 Previous Clinical Trials
9 Total Patients Enrolled

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT01979211 — Phase 2
Head and Neck Cancers Research Study Groups: Cetuximab and Radiation
Head and Neck Cancers Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT01979211 — Phase 2
Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01979211 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Mar 2025