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

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age22+

SponsorJonathan Schoenfeld, MD, MPH

About this trial

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 criteria

Qualifiers

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.

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.

Disqualifiers

Patients with AJCC 2017 8th edition stage IVC (metastatic) disease; or patients with fixed cervical nodal disease suggesting extranodal extension or N3 disease as suggested by lymph nodes measuring >6 cm.

Subject who has had prior radiation and/or chemotherapy for head and neck cancer.

Any history of oncologic surgical resection (transoral robotic surgery, TORS) or oncologic neck dissection prior to undergoing definitive RT or chemoradiation. Note: prior tonsillectomy as part of identification of the primary tumor site or biopsy and excisional nodal biopsy is/are acceptable provided the patient would be standardly treated to definitive treatment doses of therapy off protocol. Patients with HPV-associated unknown primary should not have undergone a neck dissection to be eligible.

Undetectable baseline HPV ctDNA result by NavDx® testing or detectable baseline HPV ctDNA result for subtypes 18, 31, 33, or 35.

Trial design

Treatments tested in this trial

NavDx HPV ctDNA Testing
Radiotherapy
Chemotherapy drug

Treatment groups

145 Participants

are divided into 2 treatment groups

Locations

Brigham and Women's Hospital02115, BostonMassachusetts, United States

Dana Farber Cancer Institute02215, BostonMassachusetts, United States

Sponsors and collaborators

Jonathan Schoenfeld, MD, MPH

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

Naveris

Collaborator

Source ClinicalTrials.gov