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Monoclonal Antibodies
Radiation + Drug for Oropharyngeal Cancer
Phase 3
Waitlist Available
Led By Maura Gillison, MD, PhD
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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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.
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
Behavioral Risk Assessment Survey (BRASS) at Baseline.
Distribution of First Progression Events
EORTC QLQ-C30 at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.
+24 moreTrial 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
13,717 Previous Clinical Trials
40,952,377 Total Patients Enrolled
NRG OncologyOTHER
232 Previous Clinical Trials
99,792 Total Patients Enrolled
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
63,940 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My liver and kidneys are working well.I have received chemotherapy for my current cancer.I have had radiation in the same area where my current cancer is located.All of my cancer and affected lymph nodes have been surgically removed.I have been cancer-free for at least 3 years from a previous cancer.I have been mostly active and able to carry on all pre-disease activities without restriction recently.I am HIV positive with no AIDS-defining illness and my CD4 count is at least 350.My cancer is in an early stage and may have spread to nearby lymph nodes.My cancer has spread to areas below my collarbone or further.I had a minor surgery to remove up to 4 lymph nodes from my neck.My cancer originates from the mouth, nasopharynx, hypopharynx, or larynx.I have more than one primary tumor or tumors in both sides of a body part.My cancer can be seen or measured on scans.I have been diagnosed with squamous cell carcinoma in my throat.My cancer is p16 positive, confirmed by a specialized test.I have previously received cetuximab or other anti-EGFR therapy.I am not pregnant and willing to use birth control during the trial.
Research Study Groups:
This trial has the following groups:- Group 1: IMRT + Cisplatin
- Group 2: IMRT + Cetuximab
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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