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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
No Placebo-Only Group
Pivotal Trial

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
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I am 18 years old or older.
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I am HIV positive with no AIDS-defining illness and my CD4 count is at least 350.
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My cancer can be seen or measured on scans.
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I have been diagnosed with squamous cell carcinoma in my throat.
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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:
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I have received chemotherapy for my current cancer.
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I have had radiation in the same area where my current cancer is located.
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All of my cancer and affected lymph nodes have been surgically removed.
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I am not pregnant and willing to use birth control during the trial.
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I have previously received cetuximab or other anti-EGFR therapy.
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My cancer is in an early stage and may have spread to nearby lymph nodes.
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My cancer has spread to areas below my collarbone or further.
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My cancer originates from the mouth, nasopharynx, hypopharynx, or larynx.
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I have more than one primary tumor or tumors in both sides of a body part.

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.
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,130 Total Patients Enrolled
138 Trials studying Precancerous Conditions
43,351 Patients Enrolled for Precancerous Conditions
NRG OncologyOTHER
239 Previous Clinical Trials
102,178 Total Patients Enrolled
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
63,937 Total Patients Enrolled
Andy M. Trotti, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
1 Previous Clinical Trials
250 Total Patients Enrolled
Maura Gillison, MD, PhDPrincipal InvestigatorOhio State University
2 Previous Clinical Trials
540 Total Patients Enrolled
1 Trials studying Precancerous Conditions
500 Patients Enrolled for Precancerous Conditions

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01302834 — Phase 3
Precancerous Conditions Research Study Groups: IMRT + Cisplatin, IMRT + Cetuximab
Precancerous Conditions 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
~68 spots leftby Dec 2025
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