Actively Recruiting
Led by Jonathan Schoenfeld, MD, MPH · Updated on 2025-07-30
145
Participants Needed
2
Research Sites
104 weeks
Total Duration
J
Jonathan Schoenfeld, MD, MPH
Lead Sponsor
N
Naveris
Collaborating Sponsor
Researchers are evaluating if treatment for HPV-related oropharynx cancers can be tailored using clinical features like tumor stage and smoking status combined with an investigational HPV blood test called NavDx HPV ctDNA testing. This Phase II trial studies the safety and effectiveness of adjusting radiation and chemotherapy doses based on HPV blood test results and clinical risk factors in participants with HPV-associated oropharyngeal squamous cell carcinoma. Participants receive NavDx HPV ctDNA blood tests at multiple points, including during treatment and follow-up. Depending on risk, some receive lower radiation doses for 5-6 weeks, while higher-risk participants get standard radiation for 7-8 weeks. Chemotherapy with Cisplatin or Carboplatin and Paclitaxel may be given alongside radiation, with dosing schedules varying by participant risk. The study treatment lasts up to 7 weeks, followed by long-term monitoring. During the study, participants undergo eligibility screening, treatment with radiation and possibly chemotherapy, and regular blood tests to measure HPV ctDNA levels. Follow-up visits occur for up to 5 years to monitor progression-free survival at 2 years and overall survival, as well as distant failure rates, response to treatment, quality of life through surveys, and safety assessments. Blood samples will be stored for future research. This comprehensive monitoring helps assess treatment response and disease outcomes over time.
CONDITIONS
Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 to 8 weeks
Participants receive NavDx HPV ctDNA blood tests to measure HPV DNA levels at Week 4 and at the end of treatment. Radiation therapy is administered daily Monday through Friday for 5-8 weeks depending on risk level. Some participants also receive chemotherapy with doses and agents determined by the study doctor.
Daily visits for radiation therapy Monday through Friday; chemotherapy infusions weekly or every 21 days depending on regimen
Duration - Up to 5 years
Participants have follow-up visits for up to 5 years after treatment including regular NavDx HPV ctDNA blood tests to monitor for cancer recurrence.
Blood tests at 3, 6, 9, and 12 months after treatment; then every 6 months in years 2 and 3; additional visits every 3 to 6 months for evaluations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
J
Jonathan Schoenfeld, MD, MPH
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Glenn J Hanna, Tulika R Gupta, Lorenzo Trippa...
https://pubmed.ncbi.nlm.nih.gov/42098120