Risk-Adapted Treatment for HPV-Positive Oropharyngeal Cancer Using Blood Test - The ReACT Study

Sponsor: Jonathan Schoenfeld, MD, MPH

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04900623

Provider View

This study is exploring if treatment for HPV-related throat cancer can be personalized using a special blood test and other health factors. The study involves a blood test, radiation, and possibly chemotherapy.

Patient Parameters

Program Overview

The ReACT study is investigating whether treatment for HPV-related oropharyngeal cancer (cancer in the throat area) can be customized based on a blood test that detects HPV DNA and other clinical factors like tumor stage and smoking status. The study includes a blood test called NavDx® to measure HPV DNA, radiation therapy, and chemotherapy for some participants. Researchers aim to see if adjusting treatment based on these factors can improve outcomes.

Description

This study involves using a blood test to measure HPV DNA levels, which may come from the cancer itself, along with radiation therapy and chemotherapy for some participants. The study procedures include checking if participants are eligible, providing treatments, and conducting follow-up visits.

The treatments and tests in this study are:

  • NavDx® HPV ctDNA testing: A blood test to measure HPV DNA levels.
  • Radiation therapy: Standard treatment for this cancer, sometimes combined with chemotherapy. The study is testing if lower doses of radiation and chemotherapy can be effective for certain patients.
  • Chemotherapy: Drugs like Cisplatin, or Carboplatin and Paclitaxel may be used, but not all participants will receive these.

The study will last up to 7 weeks, with follow-up for 5 years. About 145 people are expected to participate. The NavDx® test is investigational and not FDA-approved for treatment decisions, but it is used in clinical settings to measure HPV DNA levels. This Phase II trial aims to test the safety and effectiveness of this approach in treating HPV-related oropharyngeal cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed stage I, II, or III HPV-related oropharyngeal cancer (cancer in the throat area), excluding certain advanced stages.
  • HPV status confirmed by specific tests on a tissue sample.
  • Willing to provide blood and tissue samples before, during, and after treatment.
  • Detectable HPV DNA in blood before treatment using the NavDx® test.
  • Age 22 or older.
  • Good overall health with a performance status of 2 or less.
  • Adequate organ and marrow function if receiving chemotherapy.
  • Planning to receive non-surgical treatment for HPV+ oropharyngeal cancer.
  • Able to understand and sign a consent form.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and use effective contraception. Men must also use contraception if sexually active with women of childbearing potential.

Exclusion Criteria

  • Advanced stage cancer that has spread or certain large lymph node involvement.
  • Previous radiation or chemotherapy for head and neck cancer.
  • Previous major cancer surgery in the head and neck area, except for certain minor procedures.
  • Undetectable or certain types of HPV DNA in blood before treatment.
  • Pregnant or breastfeeding women.
  • Uncontrolled health conditions that could interfere with the study.
  • Another active cancer requiring treatment, except for certain skin cancers or low-risk prostate cancer.

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