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Radiation Therapy + Cetuximab for Head and Neck Cancer

Phase 3
Waitlist Available
Research Sponsored by Radiation Therapy Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have undergone gross total resection of the primary tumor with curative intent within the past 7 weeks with surgical pathology demonstrating ≥ 1 of the following criteria for 'intermediate' risk of recurrence
Histologically confirmed squamous cell carcinoma of the head and neck (including variants)
Must not have
History of any lymphoproliferative disorder
History of active malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to date of death or last follow-up. maximum follow-up at time of analysis was 12.1 years.
Awards & highlights

Summary

This trial is comparing radiation therapy alone to radiation therapy given with the drug cetuximab to see if it is more effective in treating patients who have had surgery for locally advanced head and neck cancer.

Who is the study for?
This trial is for individuals who've had surgery for locally advanced head and neck cancer, specifically squamous cell carcinoma. They should be in the early stages of the disease (T1, N1-2, M0 or T2-4a, N0-2, M0) and have 'intermediate' risk of recurrence. People with a history of other cancers within 5 years (except certain skin cancers), lymphoproliferative disorders, or living outside the US cannot participate.
What is being tested?
The study is examining if adding cetuximab to intensity-modulated radiation therapy (IMRT) improves outcomes compared to IMRT alone after surgery. It's a phase III trial where patients are randomly assigned to either receive radiation only or radiation plus cetuximab.
What are the potential side effects?
Cetuximab can cause allergic reactions, skin rash, low magnesium levels, and sometimes breathing problems. Radiation therapy may lead to skin changes at the treated site, fatigue, dry mouth/throat issues due to mucosal irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had surgery to remove my tumor completely within the last 7 weeks, aiming for a cure.
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I have been diagnosed with squamous cell carcinoma in the head or neck.
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My cancer is in an early stage but may have spread to nearby lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a condition where my lymphocytes grow abnormally.
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I have a history of cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to date of death or last follow-up. maximum follow-up at time of analysis was 12.1 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to date of death or last follow-up. maximum follow-up at time of analysis was 12.1 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Alive (Overall Survival)
Secondary study objectives
Disease-free Survival
Percentage of Participants With Other ≥ Grade 3 Adverse Events Related to Protocol Treatment
Percentage of Participants With Other ≥ Grade 3 Late Adverse Events Related to Protocol Treatment
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II: IMRT plus cetuximabExperimental Treatment2 Interventions
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks). Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
Group II: Arm I: Intensity-Modulated RadiotherapyActive Control1 Intervention
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
FDA approved
intensity-modulated radiation therapy
2008
Completed Phase 3
~1490

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,298 Total Patients Enrolled
NRG OncologyOTHER
236 Previous Clinical Trials
101,573 Total Patients Enrolled
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
64,224 Total Patients Enrolled

Media Library

Intensity-Modulated Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT00956007 — Phase 3
Head and Neck Cancers Research Study Groups: Arm II: IMRT plus cetuximab, Arm I: Intensity-Modulated Radiotherapy
Head and Neck Cancers Clinical Trial 2023: Intensity-Modulated Radiation Therapy Highlights & Side Effects. Trial Name: NCT00956007 — Phase 3
Intensity-Modulated Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT00956007 — Phase 3
~46 spots leftby Sep 2025
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