NCT04900623 · Jonathan Schoenfeld, MD, MPH
Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study
What this study 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 experimental HPV blood test.
View original scientific description
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.
Interventions
DEVICE
NavDx HPV ctDNA Testing
Blood will be collected and shared with an outside lab for analysis. This test will be done at Week 4 and at End of Treatment. This test will be done at at End of Treatment and in follow-up at 3, 6, 9, and 12 months after completing the study treatment. In years 2 and 3 after treatment, the test will be collected every 6 months or twice a year. The specimens will be identifiable. The specimens will be banked for future use.
RADIATION
Radiotherapy
Radiation Therapy (administered daily, Monday-Friday). Higher risk participants will receive standard radiation dose for up to 7-8 weeks. Lower risk participants will receive a lower dose and treatment will only last 5-6 weeks.
DRUG
Chemotherapy drug
Chemotherapy and radiation therapy are both considered standard treatments * Bolus Cisplatin: Infused every 21 days for up to 2 or 3 doses. * Weekly Cisplatin or Carboplatin with Paclitaxel: Infused weekly during radiation therapy.
Primary outcome measures
Progression Free Survival 2 Years
Time frame: 2 Years
Progression-free survival (PFS) is defined as the time from the date of study registration to first invasive local, regional, distant progression, or death due to any cause. Participants alive without progression are censored at date of last disease evaluation
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants must meet the following eligibility criteria at the time of screening to be eligible to participate in the study:
- Subject must have histologically or cytologically confirmed, stage I, II, or III (N3 disease excluded), HPV associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma, as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition staging. \-- Patients with HPV-associated disease of unknown primary (cT0) are eligible
- HPV status should be confirmed on tissue biopsy or cytologic sample by any of the following:
- Immunohistochemical staining for p16 with ≥70% expression
- Confirmatory DNA testing (PCR or ISH) for high-risk subtype
- Willing to provide blood and tissue from a diagnostic biopsy and blood samples before, during, and after treatment.
- Detectable HPV ctDNA blood sample at baseline, prior to treatment, using the NavDx® assay that detects HPV subtype 16
- Age 22 years or older
- ECOG performanc
Where
- Boston, Massachusetts
Collaborators
Naveris
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 30, 2025 · Source of record for eligibility and locations