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RecruitingPhase 2NCT04900623

Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study

Sponsor

Jonathan Schoenfeld, MD, MPH

Enrollment

145 participants

Start Date

Jul 2, 2021

Study Type

INTERVENTIONAL

Conditions

HPV Positive Oropharyngeal Squamous Cell CarcinomaHPV-Related Squamous Cell CarcinomaClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8HPV-Associated Oropharyngeal Squamous Cell CarcinomaHPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 StageHPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical StageHPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Pathologic Stage

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)

Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study uses a blood test that detects HPV DNA (the virus linked to certain throat cancers) to personalize and adjust treatment intensity for people with HPV-related throat cancer. The goal is to give less intensive treatment to lower-risk patients while maintaining excellent results. **You may be eligible if...** - You have been diagnosed with HPV-associated cancer of the throat (tonsil or base of tongue), stage I, II, or III - Your HPV status has been confirmed by tissue testing - A specific HPV blood test (NavDx) is detectable before treatment starts - You are 22 years old or older - You are in good general health (ECOG performance status 0-2) **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have N3 lymph node involvement - Your HPV blood test is undetectable before treatment - You have had prior radiation to the head and neck - You have a serious medical condition that prevents standard treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENavDx 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.

RADIATIONRadiotherapy

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.

DRUGChemotherapy 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.

Locations(2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

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NCT04900623

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