Neck Radiation +/− Cisplatin for Oropharyngeal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of neck radiation and the chemotherapy drug Cisplatin to evaluate their effectiveness in treating oropharyngeal cancer, particularly in patients with p16-positive cancer. Researchers aim to determine how well these treatments work for patients with cancer confined to one side of the neck or with specific lymph node involvement. Suitable candidates for this trial have been diagnosed with squamous cell carcinoma in the oropharynx, have a history of smoking, and have specific lymph node conditions without cancer crossing the midline of the neck. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that cisplatin plays an important role in treating HPV-positive oropharyngeal cancer. While effective, it can cause side effects such as painful mouth sores, nausea, vomiting, and a decrease in white blood cells, which help fight infections.
Radiation therapy, another component of this trial, also causes side effects. Patients often experience soreness or dryness in their mouths. Despite these effects, radiation therapy remains a well-established treatment for this type of cancer.
Both treatments have a well-documented safety record. Although side effects are known, they can usually be managed. Joining the trial will help researchers learn more about balancing the benefits and side effects for patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it explores combining neck radiation with cisplatin for treating oropharyngeal cancer. Unlike standard treatments that often use radiation alone or chemotherapy separately, this approach investigates the potential benefits of using them together, which might enhance effectiveness against cancer cells. Cisplatin is a powerful chemotherapy drug that can damage the DNA of cancer cells, potentially making them more sensitive to radiation. This trial aims to determine whether this combination can improve outcomes, especially for patients with more extensive neck cancer involvement.
What evidence suggests that this trial's treatments could be effective for oropharyngeal cancer?
This trial will compare the effectiveness of neck radiation with or without the addition of cisplatin for treating oropharyngeal cancer. Research has shown that cisplatin effectively treats p16+ oropharyngeal cancer. Studies have found that patients have better survival rates when they receive the right amount of cisplatin. Specifically, those who received a total dose of 200 mg or more had higher overall survival rates, with 89.7% having no detectable cancer afterward.
Radiation therapy, particularly intensity-modulated radiation therapy (IMRT), plays a crucial role in treating oropharyngeal cancer. It protects organs while effectively managing the cancer. Survival rates are high, and it has a strong record of preventing cancer recurrence. Together, these treatments offer a promising approach for people with p16+ oropharyngeal cancer. Participants in this trial will receive either radiation therapy alone or in combination with cisplatin, depending on their assigned cohort.36789Who Is on the Research Team?
Thomas Galloway, MD
Principal Investigator
Fox Chase Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with p16+ oropharyngeal cancer, who have not had prior systemic therapy or neck surgery for the cancer. They should be in good physical condition (ECOG 0-1), without metastatic disease, bilateral neck adenopathy, or a history of severe allergic reactions to Technetium-99m-tilmanocept. Tumors must not cross midline and patients should have adequate organ function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment
Patients positive for p16 status are approached for consent during the pre-treatment intake process
Treatment
Participants receive unilateral neck radiation for 6-7 weeks or until unacceptable toxicity or withdrawal of consent
Follow-up
Participants are monitored for disease free survival (DFS) and overall survival (OS) until 24 months after completion of study treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Radiation Therapy
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fox Chase Cancer Center
Lead Sponsor
Cardinal Health
Industry Sponsor