At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed stage I, II, or III (N3 disease excluded) HPV-associated oropharyngeal squamous cell carcinoma
- ✓HPV status confirmed by p16 immunohistochemistry ≥70% or DNA testing (PCR/ISH) for high-risk subtype
- ✓Detectable HPV ctDNA at baseline using NavDx assay detecting HPV subtype 16
- ✓Age 22 years or older
- ✕AJCC 2017 8th edition stage IVC (metastatic) disease
- ✕Fixed cervical nodal disease with extranodal extension or N3 disease (lymph nodes >6 cm)
- ✕Prior radiation and/or chemotherapy for head and neck cancer
- ✕Prior oncologic surgical resection (TORS) or oncologic neck dissection, except tonsillectomy for diagnosis or excisional nodal biopsy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study
In Brief
A Phase 2 clinical trial evaluating NavDx HPV ctDNA Testing, Radiotherapy, and 1 other intervention for HPV-Associated Oropharyngeal Squamous Cell Carcinoma and 11 related conditions. Currently recruiting, targeting 145 participants across 2 sites.
Signals
Detailed Summary
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)
Study Details
Timeline
Interventions
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 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.
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.