Reduced Radiation + Chemotherapy for Oral Squamous Cell Carcinoma
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to demonstrate that participants with HPV positive and hypoxia negative T1-2, N1-2c (AJCC, 7th ed.) oropharyngeal squamous cell carcinoma receiving a major de-escalated radiation therapy with 2 cycles of standard chemotherapy is not inferior to comparable subjects treated with the current standard chemoradiation.Accrual for Cohort A has been completed.Cohort B is active and continues to enroll participants where surgery is optional and proton is allowed.
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.
Is the combination of reduced radiation and chemotherapy safe for treating oral squamous cell carcinoma?
Studies show that the combination of chemotherapy drugs like 5-Fluorouracil (5-FU) and cisplatin or carboplatin with radiation has been used in treating head and neck cancers. While these treatments can have side effects like nausea and blood cell changes, they are generally considered to have an acceptable safety profile.12345
What makes this treatment for oral squamous cell carcinoma unique?
What data supports the effectiveness of the treatment for oral squamous cell carcinoma?
Research shows that the combination of cisplatin and 5-fluorouracil (5-FU) is a standard and effective regimen for treating advanced head and neck cancers, including squamous cell carcinoma. Additionally, carboplatin, which is similar to cisplatin but with less severe side effects, has shown promising results when combined with 5-FU and radiation therapy, offering potential benefits for patients with head and neck cancers.12378
Who Is on the Research Team?
Nancy Lee, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
Adults with HPV-associated oropharyngeal squamous cell carcinoma, stages T1-2 N1-2c, can join this trial. They must have good blood counts, kidney and liver function, and no history of chemotherapy for the cancer being studied. Pregnant women must test negative. Those with prior head/neck radiation or other cancers (except certain skin cancers) within 3 years are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Imaging
Participants undergo BF-FMISO PET/CT imaging to determine hypoxia status
Treatment
Participants receive 30Gy radiation therapy concurrent with 2 cycles of chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 30 Gy over 3 weeks
- 5Fluorouracil
- Carboplatin
- Cisplatin
- Proton Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor