Low-Dose Chemoradiotherapy for Oropharyngeal Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you cannot be on any other anticancer therapy while participating in this trial.
What data supports the effectiveness of the treatment PTV50.4, PTV56 for oropharyngeal cancer?
Research shows that reducing the dose of chemoradiation (a combination of chemotherapy and radiation therapy) for HPV-positive oropharyngeal cancer can lead to good functional outcomes and quality of life, while still being effective. This suggests that lower doses, like those in PTV50.4 and PTV56, might be beneficial for patients.12345
Is low-dose chemoradiotherapy for oropharyngeal cancer safe?
Studies on low-dose chemoradiotherapy for HPV-positive oropharyngeal cancer show it can be safe, with some patients experiencing side effects like severe mouth sores and difficulty swallowing. However, these side effects are generally less severe compared to standard treatments, and long-term follow-up is needed to confirm safety.26789
How does the treatment PTV50.4, PTV56 for oropharyngeal cancer differ from other treatments?
This treatment involves a lower dose of chemoradiotherapy, which means using less radiation and chemotherapy than standard treatments. This approach aims to reduce long-term side effects while maintaining effectiveness, especially for patients with human papillomavirus-positive oropharyngeal cancer.123410
What is the purpose of this trial?
The purpose of this study is to establish the efficacy and toxicity of low dose chemoradiotherapy after induction chemotherapy in patients with locally advanced HPV+ oropharynx cancer and establish prognostic factors that would apply to help select patients for this treatment in the future.
Research Team
Marshall R. Posner
Principal Investigator
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Adults over 18 with HPV+ oropharyngeal cancer that's not been treated before can join. They need a biopsy for testing, no heavy alcohol use in the last 6 months, and good organ function. Pregnant women, those unwilling to use contraception, people with other cancers (except certain types), severe neuropathy or hearing loss, lung disease, recent heart attack or serious illness can't participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Chemotherapy
Participants receive induction chemotherapy to establish efficacy and toxicity before chemoradiotherapy
Reduced Dose Chemoradiotherapy
Participants receive daily radiation treatment with intensity-modulated radiotherapy (IMRT) for 5 days per week
Follow-up
Participants are monitored for safety, effectiveness, and long-term toxicity after treatment
Treatment Details
Interventions
- PTV50.4
- PTV56
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor