Tailored Therapy for HPV-Related Oropharyngeal Cancer
Trial Summary
What is the purpose of this trial?
This research is being conducted to understand if treatment can be tailored for participants with HPV-related oropharynx cancers using both clinical features (stage of the tumor, smoking status) combined with an investigational HPV blood test. The names of the test and treatments involved in this study are: * NavDx® HPV ctDNA testing (HPV blood test) * Radiation therapy * Chemotherapy: Cisplatin, or Carboplatin and Paclitaxel (not all participants receive any or all of these agents)
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 trial coordinators or your doctor to get specific guidance based on your situation.
What data supports the effectiveness of the treatment for HPV-related oropharyngeal cancer?
Is the treatment for HPV-related oropharyngeal cancer safe?
Cisplatin, often used with radiation therapy for HPV-related oropharyngeal cancer, is known to cause long-term side effects, which has led to exploring other treatments like carboplatin that might have fewer side effects. Radiation therapy alone is also considered, but it can still cause significant long-term toxicity.34567
How is the treatment with Cisplatin, Paclitaxel, and Radiotherapy unique for HPV-related oropharyngeal cancer?
This treatment is unique because it combines Cisplatin and Paclitaxel with Radiotherapy, which is different from other approaches that might use Cetuximab instead of Cisplatin to reduce side effects. Cisplatin is often preferred for its effectiveness, especially in HPV-positive cases, despite its higher toxicity compared to alternatives like Cetuximab.23589
Research Team
Jonathan D. Schoenfeld, MD MPH
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Adults aged 22+ with HPV-related oropharyngeal cancer (stage I-III, excluding N3 disease) who have not had prior head and neck cancer treatments. Participants must be able to provide blood samples, have adequate organ function for chemotherapy, and use effective contraception if of childbearing potential.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive radiation therapy and possibly chemotherapy based on risk assessment using HPV ctDNA testing
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cisplatin
- NavDx HPV ctDNA Testing
- Paclitaxel
- Radiotherapy
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?
Jonathan Schoenfeld, MD, MPH
Lead Sponsor
Naveris
Collaborator