Radiation + Cetuximab vs Chemotherapy for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two treatment approaches for advanced head and neck cancer. One group receives cetuximab, a medication targeting cancer cell growth, combined with precise radiation therapy. The other group receives chemotherapy with carboplatin and paclitaxel, also alongside radiation therapy. The study seeks participants diagnosed with advanced head and neck cancer who have not undergone prior treatment and cannot receive the standard treatment drug, cisplatin. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer treatments.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that cetuximab is generally well-tolerated by patients with head and neck cancer. Its side effects are usually milder than those from traditional chemotherapy drugs. The most common side effect is a skin rash, while serious side effects occur less frequently.
Studies have found that the combination of carboplatin and paclitaxel is well-tolerated when used with radiation therapy. Some patients might experience a significant drop in white blood cells, increasing the risk of infection, but these side effects can be managed. Both treatments aim to minimize discomfort while effectively treating cancer.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for head and neck cancer because they offer new ways to tackle the disease. Unlike the standard chemotherapy options like cisplatin, which are known for their harsh side effects, this trial explores the potential of combining radiation with either cetuximab or a regimen of carboplatin and paclitaxel. Cetuximab stands out because it specifically targets the epidermal growth factor receptor (EGFR), potentially curbing cancer cell growth more precisely. Meanwhile, carboplatin and paclitaxel provide a different chemotherapy approach that might be less toxic than traditional options. These innovative combinations could lead to more effective and tolerable treatments for patients.
What evidence suggests that this trial's treatments could be effective for advanced head and neck cancer?
This trial will compare two treatment approaches for head and neck cancer. In one arm, participants will receive cetuximab with intensity-modulated radiation therapy (IMRT). Research has shown that cetuximab, when combined with radiation therapy, yields promising results, with a 45.6% five-year survival rate compared to 36.4% for radiation alone. Cetuximab targets a protein called EGFR on cancer cells, helping to stop their growth.
In the other arm, participants will receive carboplatin and paclitaxel combined with IMRT. These drugs are effective treatment options; paclitaxel stops cancer cells from dividing, while carboplatin helps to kill or slow their growth. They have been successfully used against various cancers and work well with radiation. Both treatment options are valuable for those who cannot take cisplatin, another cancer drug.678910Who Is on the Research Team?
Loren K Mell
Principal Investigator
NRG Oncology
Are You a Good Fit for This Trial?
This trial is for adults with certain types of head and neck cancers (like larynx, hypopharynx, oropharynx, or oral cavity) that have not been treated before and cannot be removed by surgery. Participants must not be able to receive cisplatin due to health reasons.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation and Treatment
Participants undergo intensity modulated radiation therapy (IMRT) 5 days per week for 35 treatments. Concurrently, they receive either cetuximab or carboplatin and paclitaxel depending on the assigned arm.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including imaging and blood sample collection.
Long-term Follow-up
Participants continue to be monitored annually for progression-free survival and overall survival.
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cetuximab
- Intensity-Modulated Radiation Therapy
- Paclitaxel
Trial Overview
The study compares two treatments: one group gets radiation plus cetuximab (a targeted therapy), while the other gets radiation plus chemotherapy drugs carboplatin and paclitaxel. The goal is to see which combination works better for people who can't take cisplatin.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients undergo IMRT 5 days per week for 35 treatments. Starting within 7 days prior to radiation, patients receive a loading dose of cetuximab IV and then concurrently with radiation on day 1 of each cycle. Cycles repeat every 7 days for 7 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, or PET/CT during screening, blood sample collection throughout the study, and FDG PET/CT during follow-up.
Patients undergo IMRT 5 days per week for 35 treatments. Starting on day 1 of radiation, patients receive concurrent carboplatin IV and paclitaxel on day 1 of each cycle. Cycles repeat every 7 days for 7 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan on study and blood sample collection throughout the study. Patients may undergo PET scan or MRI during screening.
Find a Clinic Near You
Who Is Running the Clinical Trial?
NRG Oncology
Lead Sponsor
Citations
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pure.johnshopkins.edu
pure.johnshopkins.edu/en/publications/the-use-of-carboplatin-and-paclitaxel-with-daily-radiotherapy-in--3The use of carboplatin and paclitaxel with daily ...
Conclusions: Weekly carboplatin and paclitaxel given concurrently with definitive once-daily external beam radiation therapy is well tolerated ...
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