Actively Recruiting
Pilot Study of Induction Therapy Followed by Response-adaptive Treatment and Dynamic Changes in Circulating Tumor DNA in Locoregionally Advanced HPV Negative Head and Neck Squamous Cell Carcinoma
Led by University of Chicago · Updated on 2025-06-08
36
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether blood-based biomarker testing can help personalize cancer treatment for patients with locally advanced head and neck squamous cell carcinoma that is HPV-negative. This phase 1 trial focuses on patients with stage III or IV disease in areas like the oral cavity, oropharynx, hypopharynx, nasopharynx, larynx, or sinuses. The study aims to determine if circulating tumor DNA levels can predict response to treatment. All participants first receive three cycles of chemotherapy over nine weeks using paclitaxel, carboplatin, and cetuximab. After this induction chemotherapy, imaging is used to assess disease response. Those with a significant response receive low dose radiation plus chemotherapy (CRT) for 6.5 weeks, while those with limited response receive standard dose radiation plus chemotherapy for 7 weeks. The investigator selects the chemotherapy drugs given during CRT, which may include cisplatin or a regimen with paclitaxel, fluorouracil, and hydroxyurea. Throughout the study, participants undergo imaging to measure disease response and provide blood samples to measure biomarkers including circulating tumor DNA. Researchers track side effects related to treatment and evaluate long-term disease response up to two years after treatment. The main outcome measures include treatment completion rates and predictive value of tumor DNA at nine weeks. Safety and disease status are monitored regularly during and after therapy, with total involvement lasting up to two years.
CONDITIONS
Brief Title
Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have pathologically confirmed locally advanced, non-metastatic, HPV-negative head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, nasopharynx, larynx, or sinuses.
- Stage III or IV disease based on AJCC staging 8th edition.
- HPV must be ruled out by immunohistochemistry if oropharyngeal squamous cell carcinoma is diagnosed.
- Availability of at least 10 unstained 5 micron slides or willingness to undergo a new biopsy.
- Patients must be at least 18 years old.
- Measurable disease by RECIST 1.1 criteria.
- No previous radiation or chemotherapy for head and neck cancer.
- No complete surgical resection of head and neck cancer within 8 weeks prior to enrollment, except certain biopsies.
- Performance status 0-1.
- Normal organ function including leukocytes ≥ 3000/mm3, platelets ≥ 100,000/mm3, absolute neutrophil count ≥ 1,500, hemoglobin ≥ 9.0 gm/dL, AST ≤ 2.5x upper limit normal, ALT ≤ 2.5x upper limit normal, alkaline phosphatase ≤ 2.5x upper limit normal, albumin > 2.9 gm/dL, total bilirubin ≤ 1.5 mg/dL, creatinine clearance > 45 mL/min.
- Signed informed consent.
- Negative pregnancy test for women of childbearing potential within 24 hours before starting treatment.
- Women not breastfeeding.
- Contraception agreement for women of childbearing potential and sexually active men during treatment and 5 months after.
You will not qualify if you...
- Distant metastatic disease (M1).
- Unidentifiable primary tumor site.
- Medical illnesses impairing tolerance to therapy or survival (e.g., active infection, immunodeficiency, heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina, arrhythmia, psychiatric illness/social issues limiting compliance).
- Prior surgical therapy other than biopsies or organ-sparing procedures; residual measurable tumor required.
- Receiving other investigational agents.
- Diagnosis of immunodeficiency or systemic steroid/immunosuppressive therapy within 7 days prior to first trial dose.
- Active tuberculosis infection.
- Hypersensitivity to cetuximab or study drugs.
- Prior systemic anti-cancer treatment within 8 weeks.
- Additional progressing malignancy requiring active treatment (exceptions apply).
- History of HIV.
- Active Hepatitis B or C infection (eradicated infections allowed).
- Received live vaccine within 28 days before starting study therapy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 9 weeks
Participants receive 3 cycles (9 weeks) of chemotherapy with paclitaxel, carboplatin, and cetuximab to treat their cancer.
3 visits for chemotherapy cycles
Duration - 6.5 to 7 weeks
After induction chemotherapy, participants receive either low dose radiation with additional chemotherapy or standard dose radiation with additional chemotherapy based on disease response.
Weekly visits for radiation and chemotherapy
Duration - Up to 2 years after treatment ends
Participants are monitored for side effects related to the study treatment and long-term disease response.
Visits at 3 months and periodic assessments up to 2 years
Trial Site Locations
Total: 1 location
1
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
C
Clinical Trials Intake
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here