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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 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.