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New treatment option for HPV-Associated Oropharyngeal Squamous Cell Carcinoma
Official title Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study
ClinicalTrials.gov ID: NCT04900623
What this study is testing
What is Chemotherapy drug?
Chemotherapy drug is an investigational medicine, given as an once-weekly, being studied as a potential treatment for hpv-associated oropharyngeal squamous cell carcinoma.
Also referred to as Bolus Cisplatin, Cisplatin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
- Time commitment: about 7 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- Patients with AJCC 2017 8th edition stage IVC (metastatic) disease; or patients with fixed cervical nodal disease suggesting extranodal extension or...
- 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...
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 7 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.