Reduced Dose Radiotherapy for Oropharyngeal Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether 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 Reduced Dose Radiotherapy for Oropharyngeal Cancer?
Research shows that combining carboplatin with radiation therapy can lead to promising results in treating advanced oropharyngeal cancer, with some studies reporting a complete remission in 60% of patients. This suggests that using carboplatin with reduced dose radiotherapy might also be effective.12345
Is reduced dose radiotherapy with carboplatin safe for treating oropharyngeal cancer?
Carboplatin, when used with radiotherapy for head and neck cancers, generally has mild side effects like nausea and vomiting, with more serious blood-related side effects (myelosuppression) occurring at higher doses. The treatment is usually well tolerated, although some patients may experience severe mouth sores (mucositis) that can interrupt treatment.12367
How does the reduced dose radiotherapy treatment for oropharyngeal cancer differ from other treatments?
This treatment is unique because it uses a reduced dose of radiation combined with carboplatin, which has similar effects to the standard cisplatin but with potentially fewer side effects. The reduced radiation dose aims to maintain effectiveness while minimizing harmful side effects, making it a potentially safer option for patients.12478
What is the purpose of this trial?
This trial aims to directly compare a reduced radiation dose to the standard of care in HPVOPC for non-inferiority, thus allowing for direct comparison of outcomes between the two groups. The study hypothesis is that LRC and PFS at 3 years for reduced dose CRT are non-inferior to standard dose CRT.
Research Team
Marshall R. Posner
Principal Investigator
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Adults over 18 with HPV-positive oropharyngeal cancer, who haven't had previous cancer treatments and are in good physical condition. They must not be pregnant, have no other current cancers (with some exceptions), and can't have a history of significant alcohol or drug abuse within the last six months.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Chemotherapy
Participants receive three cycles of Docetaxel, Cisplatin, and 5-FU (TPF) induction chemotherapy
Radiation Therapy
Participants undergo randomization to receive either reduced (5600 cGy) or standard (7000 cGy) dose radiotherapy with weekly Carboplatin
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carboplatin
- Reduced Dose Radiation
- Standard Dose Radiation
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
Biodesign Institute
Collaborator
The Biodesign Institute
Collaborator
Arizona State University
Collaborator