The ReACT Study: Risk-adapted Therapy in HPV+ Oropharyngeal Cancer
This study, called ReACT, is for people with HPV-associated oropharyngeal (throat) cancer. It aims to see if treatment can be adjusted based on your specific tumor characteristics and a special blood test called NavDx® HPV ctDNA. This test measures HPV DNA from the cancer in your blood. You would receive radiation therapy, and some participants may also receive chemotherapy (Cisplatin, or Carboplatin and Paclitaxel). The study will compare standard radiation doses to lower doses for some participants. The main goal is to see how long people live without their cancer growing or coming back after 2 years. About 145 people are expected to join.
- Study design
- This is an interventional study with about 145 participants. It is not specified if it is randomized or blinded.
- What's involved
- You will undergo screening, receive study treatments for up to 7 weeks, and have evaluations and follow-up visits. Blood tests for NavDx® HPV ctDNA will be done at Week 4, End of Treatment, and during follow-up at 3, 6, 9, and 12 months.
- Compensation
- The NavDx® HPV ctDNA blood test will be provided free of charge. Not stated in the trial record.
- Follow-up
- Participants will be followed for 5 years from the beginning of the study. Progression-free survival will be measured at 2 years.
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NCT04900623
Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study
Recruiting
PHASE2Ages 22+InterventionalTreatmentJonathan Schoenfeld, MD, MPHInvestigator-initiated
~145 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:NavDx HPV ctDNA TestingRadiotherapyChemotherapy drug
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival 2 Years
Measured over 2 Years
Conditions
Where it's being run
2 sites across 1 statesMassachusetts2
Study leadership
- Jonathan D Schoenfeld, MD, MPH · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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 performance status ≤ 2
Participants should have adequate organ and marrow function if they are to receive chemotherapy (cisplatin, or carboplatin and paclitaxel) with radiation concurrently as determined by standard institutional guidelines and investigator preference (parameters suggested below).
absolute neutrophil count (ANC) ≥ 1000
platelet count ≥ 100,000
total bilirubin of 1.5 or less
creatinine of 1.6 or less (or a CrCl ≥50 mL/min) per institutional standards.
Planning to receive non-surgical management for HPV+ oropharyngeal cancer
Ability to understand and the willingness to sign a written informed consent document.
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of (chemo)radiation therapy. "Women of childbearing potential (WOCBP)" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level above 40 mIU/mL.
Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 1 month after treatment. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception.
Exclusion
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.
Pregnant or lactating women.
Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease is permitted if chance3 of recurrence is thought to be low.
What this trial measures
- Progression Free Survival 2 Years2 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