← Back to Search

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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to 2 years.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I had surgery to remove my cancer completely within the last 7 weeks and am at an 'intermediate' risk of it coming back.
Select...
I had surgery to remove my tumor completely within the last 7 weeks, aiming for a cure.
Select...
I have been diagnosed with squamous cell carcinoma in the head or neck.
Select...
My cancer is in an early stage but may have spread to nearby lymph nodes.
Select...
My cancer is a type of squamous cell carcinoma in the head or neck.
Select...
My cancer is in an early stage but may have spread to nearby lymph nodes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to 2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to 2 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
Overall survival
Secondary outcome measures
Adverse events (dysphagia, xerostomia, and skin toxicity) according to CTCAE, v. 4 and their relationships with patient-reported outcomes at 3, 12, and 24 months
Disease-free survival
Loco-regional control
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II: IMRT plus cetuximabExperimental Treatment2 Interventions
Patients undergo IMRT as in arm I. Patients also receive cetuximab IV over 1-2 hours once weekly beginning at least 5 days prior to the start of IMRT and continuing for 4 weeks after the completion of IMRT (for a total of 11 doses) in the absence of disease progression or unacceptable toxicity.
Group II: Arm I: Intensity-Modulated RadiotherapyActive Control1 Intervention
Patients undergo intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
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?

Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
64,224 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,914,943 Total Patients Enrolled
NRG OncologyOTHER
231 Previous Clinical Trials
100,121 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the most common conditions that intensity-modulated radiation therapy is used to improve?

"Intensity-modulated radiation therapy, a treatment that uses varying intensities of radiation to target cancer cells, can be used to treat hnscc, metastatic squamous cell carcinoma of the head and neck, as well as other conditions."

Answered by AI

At how many different medical facilities is this trial being conducted?

"There are 100 active sites for this study, which can be found in Hanover, Mount Vernon, Albuquerque and many other places. If you choose to participate in the trial, it would be most convenient to select a location near you to minimize travel requirements."

Answered by AI

Does this trial use any methods or technologies that have not been employed before?

"Research into intensity-modulated radiation therapy began in 2005 with a study of 154 sponsored by Bristol-Myers Squibb. After the first Phase 2 drug approval in 2005, there are now 136 ongoing studies involving 1362 cities and 51 countries."

Answered by AI

Does intensity-modulated radiation therapy have any negative side effects?

"There is some evidence that intensity-modulated radiation therapy is effective, and it has been tested multiple times for safety, so it received a score of 3."

Answered by AI

Are there other cases in which intensity-modulated radiation therapy has been used?

"At the moment, there are 136 ongoing clinical trials studying intensity-modulated radiation therapy. 30 of these trials are in Phase 3. Some of the studies for intensity-modulated radiation therapy are taking place in Dresden and Arizona, but there are 5679 locations running these kinds of trials altogether."

Answered by AI

How many study subjects are taking part in this experiment?

"449 other trials for head neoplasms and 136 intensity-modulated radiation therapy studies are actively recruiting patients. The study you're inquiring about was last updated on 10/25/2022 and is not currently looking for new participants."

Answered by AI

Are we still looking for volunteers for this experiment?

"The clinical trial detailed on clinicaltrials.gov is not seeking participants at this time. This study was first posted on November 1st, 2009 and was last edited on October 25th, 2022. There are 635 other trials that are actively recruiting patients."

Answered by AI

Who else is applying?

What site did they apply to?
Memorial Hermann Memorial City Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~46 spots leftby Mar 2025