Your session is about to expire
← Back to Search
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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
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 • NCT0117795643%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Cetuximab and Radiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Share this study with friends
Copy Link
Messenger