Study on Adjusting Radiation and Chemotherapy for Oropharyngeal Squamous Cell Carcinoma Based on Risk
Sponsor: University of Florida
Sponsor score: 60
Inactive
ClinicalTrials ID:NCT05268614
This clinical trial is exploring whether reducing the intensity of radiation and chemotherapy, based on specific risk factors, can effectively control oropharyngeal squamous cell carcinoma (OPSCC) in patients with a favorable prognosis.
Patient Parameters
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Program Overview
The study aims to determine if a less intense approach to radiation and chemotherapy, tailored to individual risk factors like HPV subtype and specific blood markers, can achieve similar control of oropharyngeal squamous cell carcinoma (OPSCC) as more aggressive treatments. This approach is being tested in patients who have a favorable prognosis.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a specific type of oropharyngeal cancer (T0-3 ≤4cm, N0 to N2, M0) as per medical staging guidelines.
- Cancer must test positive for HPV or p16 markers.
- Must have a scan showing no lung cancer spread within 12 weeks before starting treatment.
- Must be in good general health with a performance status of 0 to 2.
- Must have smoked less than 10 pack-years or not smoked for at least 10 years.
- Must be eligible to receive chemotherapy.
- Must have adequate blood cell counts and organ function based on recent tests.
- Women of childbearing potential must have a negative pregnancy test before treatment and use effective birth control during and after the study.
- Must agree to use contraception to prevent pregnancy during the study and for 14 months after the last treatment.
- Must provide informed consent to participate in the study.
Exclusion Criteria
- Have had previous radiation or chemotherapy for this cancer.
- Have had surgery intended to cure this cancer.
- Have had radiation to the head and neck, except for small skin cancer treatments.
- Have had chemotherapy or immunotherapy for cancer in the last 10 years.
- Have had another invasive cancer in the last 5 years, except for certain skin, prostate, or thyroid cancers.
- Have smoked more than 10 pack-years in the last 10 years.
- Are taking certain medications for rheumatoid arthritis or other conditions.
- Have severe health issues like recent heart problems, infections, or lung disease.
- Are HIV positive.
- Are unable or unwilling to use birth control during and after the study.
- Are pregnant or breastfeeding.
- Are in prison or detained for treatment of a psychiatric or physical illness.
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