Actively Recruiting
Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study
Led by Jonathan Schoenfeld, MD, MPH · Updated on 2025-07-30
145
Participants Needed
2
Research Sites
569 weeks
Total Duration
On this page
Sponsors
J
Jonathan Schoenfeld, MD, MPH
Lead Sponsor
N
Naveris
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research is being conducted to understand if treatment can be tailored for participants with HPV-related oropharynx cancers using both clinical features (stage of the tumor, smoking status) combined with an investigational HPV blood test. The names of the test and treatments involved in this study are: * NavDx® HPV ctDNA testing (HPV blood test) * Radiation therapy * Chemotherapy: Cisplatin, or Carboplatin and Paclitaxel (not all participants receive any or all of these agents)
CONDITIONS
Official Title
Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed stage I, II, or III (excluding N3) HPV-associated oropharyngeal squamous cell carcinoma
- HPV status confirmed by p16 immunohistochemistry with 70% or greater expression or confirmatory DNA testing for high-risk subtype
- Willing to provide blood and tissue samples before, during, and after treatment
- Detectable HPV ctDNA blood sample at baseline using NavDx�ae assay for HPV subtype 16
- Age 22 years or older
- ECOG performance status of 2 or less
- Adequate organ and marrow function for chemotherapy recipients (ANC ≥ 1000, platelet count ≥ 100,000, total bilirubin ≤ 1.5, creatinine ≤ 1.6 or creatinine clearance ≥ 50 mL/min)
- Planning to receive non-surgical management for HPV+ oropharyngeal cancer
- Ability to understand and sign informed consent
- Women of childbearing potential must have a negative pregnancy test within 72 hours before treatment
- Men sexually active with women of childbearing potential must agree to use effective contraception during and for one month after treatment
You will not qualify if you...
- AJCC 2017 8th edition stage IVC (metastatic) disease or fixed cervical nodal disease suggesting extranodal extension or N3 disease (lymph nodes >6 cm)
- Prior radiation or chemotherapy for head and neck cancer
- Any oncologic surgical resection or neck dissection prior to definitive radiation or chemoradiation (except tonsillectomy or biopsy)
- Undetectable baseline HPV ctDNA by NavDx or detectable HPV ctDNA for subtypes 18, 31, 33, or 35
- Pregnant or lactating women
- Uncontrolled illness including symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting study compliance
- Known additional progressing malignancy requiring active treatment (except certain skin cancers, in situ cervical cancer, or low-risk prostate cancer under surveillance)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
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
Research Team
J
Jonathan Schoenfeld, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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