← Back to Search

Monoclonal Antibodies

Radiation + Drug for Oropharyngeal Cancer

Phase 3

Waitlist Available

Led By Andy M. Trotti, MD

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

Age ≥ 18

Patients who are HIV positive but have no prior AIDS-defining illness and have CD4 cells of at least 350/mm3 are eligible

Must not have

Prior systemic chemotherapy for the study cancer

Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to last follow-up. analysis was to occur after 180 deaths were reported. analysis occurred after 133 deaths were reported. maximum follow-up at time of analysis was 6.5 years.

Awards & highlights

Summary

This trial is comparing radiation therapy with cisplatin to radiation therapy with cetuximab to see which is more effective in treating oropharyngeal cancer.

Who is the study for?

Adults with oropharyngeal cancer, specifically squamous cell carcinoma, who haven't had prior chemotherapy or radiotherapy for it. They should have a good performance status and no severe health issues like recent heart attacks or uncontrolled infections. HIV-positive patients can join if they don't have AIDS-defining conditions.

What is being tested?

This trial is testing whether radiation therapy combined with either cisplatin (a chemotherapy drug) or cetuximab (a monoclonal antibody that targets cancer cells) is more effective in treating patients with cancers of the throat area.

What are the potential side effects?

Cisplatin may cause nausea, kidney damage, hearing loss, and nerve damage. Cetuximab can lead to skin reactions, low magnesium levels, and infusion-related reactions. Radiation therapy might result in skin irritation and fatigue.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

I am HIV positive with no AIDS-defining illness and my CD4 count is at least 350.

Select...

My cancer can be seen or measured on scans.

Select...

I have been diagnosed with squamous cell carcinoma in my throat.

Select...

My cancer is p16 positive, confirmed by a specialized test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have received chemotherapy for my current cancer.

Select...

I have had radiation in the same area where my current cancer is located.

Select...

All of my cancer and affected lymph nodes have been surgically removed.

Select...

I am not pregnant and willing to use birth control during the trial.

Select...

I have previously received cetuximab or other anti-EGFR therapy.

Select...

My cancer is in an early stage and may have spread to nearby lymph nodes.

Select...

My cancer has spread to areas below my collarbone or further.

Select...

My cancer originates from the mouth, nasopharynx, hypopharynx, or larynx.

Select...

I have more than one primary tumor or tumors in both sides of a body part.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to last follow-up. analysis was to occur after 180 deaths were reported. analysis occurred after 133 deaths were reported. maximum follow-up at time of analysis was 6.5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to last follow-up. analysis was to occur after 180 deaths were reported. analysis occurred after 133 deaths were reported. maximum follow-up at time of analysis was 6.5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to last follow-up. analysis was to occur after 180 deaths were reported. analysis occurred after 133 deaths were reported. maximum follow-up at time of analysis was 6.5 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

Overall Survival

Secondary study objectives

Distribution of First Progression Events

Percentage of Participants Experiencing Early Death

Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 1 Month After End of Study Treatment

+15 more

Trial Design

2Treatment groups

Active Control

Group I: IMRT + CisplatinActive Control2 Interventions

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Group II: IMRT + CetuximabActive Control2 Interventions

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,013 Total Patients Enrolled

NRG OncologyOTHER

236 Previous Clinical Trials

101,288 Total Patients Enrolled

Radiation Therapy Oncology GroupLead Sponsor

190 Previous Clinical Trials

63,939 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01302834 — Phase 3

Head and Neck Cancers Research Study Groups: IMRT + Cisplatin, IMRT + Cetuximab

Head and Neck Cancers Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT01302834 — Phase 3

Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01302834 — Phase 3

~69 spots leftby Sep 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.