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NBTXR3 +/− Cetuximab for Head and Neck Cancer
Study Summary
This trial is testing a new cancer treatment against the current standard of care to see if it is more effective and has fewer side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I do not have serious heart rhythm problems.My head or neck cancer has returned but I haven't had chemo or radiation for it.My head or neck cancer is in an early or specific advanced stage.My cancer is confirmed as squamous cell carcinoma in specific areas of the head or neck.I can undergo radiation therapy with the goal of curing my condition.My cancer is classified as T3-T4 or T2 with significant lymph node involvement.I am a candidate for radiation therapy as my main treatment.I am not pregnant, not nursing, and if of childbearing potential, I am willing to use contraception during and up to 150 days after the treatment.I am 65 years old or older.My magnesium levels are normal and I might receive cetuximab treatment.My cancer originates from specific head, neck areas, or is a certain non-squamous type.I have had treatment for head and neck cancer before.My doctor can inject medicine directly into my tumor.You have been chewing betel nut within the past 6 months before joining the study.I do not have severe allergies to cetuximab or ongoing lung disease.I have severe heart failure diagnosed within the last 6 months.My oropharyngeal cancer's HPV status is known.My organs and bone marrow are working well.You are expected to live for at least 6 more months.I don't have another cancer that could affect this treatment's safety or results.I can take care of myself and am up and about more than half of my waking hours.My tumor has features that could lead to serious bleeding.
- Group 1: Arm A
- Group 2: Arm B
- 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.
- 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.
Frequently Asked Questions
What are some similar studies that have been done using NBTXR3?
"There are 137 ongoing studies and 32 trials in Phase 3 for NBTXR3. Most of these trials are based in Dresden, Arizona, but there are 6111 locations running clinical trials for NBTXR3 globally."
How is NBTXR3 used to improve patients' conditions?
"NBTXR3 is the most common form of pharmacotherapy, but it can also be used to treat other conditions such as metastatic squamous cell carcinoma of the head and neck (hnscc), regionally advanced squamous cell carcinoma of the head and neck, and squamous cell carcinoma."
Can patients sign up for this test currently?
"That is accurate, the website provides updated information that this clinical trial is still enrolling patients. The original posting date was 1/5/2022, with the most recent update on 3/22/2022. They are expecting to have 500 patients total at the one site."
What are some possible side effects of NBTXR3?
"NBTXR3 is a Phase 3 trial medication, so it has some efficacy data and multiple rounds of safety data, giving it a score of 3."
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