Actively Recruiting
Adaptive De-Intensified Radiotherapy Using Circulating Tumor DNA in HPV-Associated Oropharyngeal Cancer
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-03-24
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well using circulating tumor DNA to guide lower dose radiation therapy works for patients with human papillomavirus (HPV)-associated oropharyngeal cancer. This phase II trial compares the effects of reduced dose radiation combined with chemotherapy to the usual standard dose chemotherapy in patients who clear HPV particles from their blood. The goal is to assess tumor response and side effects with this adaptive treatment approach. Participants receive external beam radiotherapy 5 days a week for 4 weeks along with weekly or every 3 weeks chemotherapy using cisplatin, carboplatin, or paclitaxel. Blood samples are collected at week 4 to measure tumor DNA levels, and patients are assigned to one of two groups based on whether their tumor DNA has reduced by more than 95%. Those with reduced tumor DNA receive radiation for 5 weeks and chemotherapy for 5 weeks, while those without receive radiation and chemotherapy for 7 weeks. PET/CT scans and blood tests are done throughout the trial. During the study, participants undergo regular PET/CT imaging, blood sample collections, and complete questionnaires about swallowing function. After treatment, patients are followed every 3 months for up to 2 years to monitor tumor response, progression-free survival, and side effects. Researchers track acute and long-term toxicities and quality of life measures to understand the impact of the adaptive lower dose therapy compared to standard care.
CONDITIONS
Brief Title
Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed squamous cell carcinoma of the oropharynx (including unknown primary, base of tongue, tonsil, oropharyngeal walls, soft palate)
- p16 positive immunohistochemical staining confirmed by central review if done outside
- Clinical stage T0, N1-N2, T1-2, N1-N2, or T3-T4, N0-2 without distant metastases
- Measurable disease at primary site or lymph nodes confirmed clinically or radiographically
- Pretreatment PET/CT scan from base of skull to mid-thigh completed prior to enrollment
- Tumor tissue modified HPV virus (TTMV-HPV) particles in plasma cell free DNA >= 200 copies/mL at baseline
- Smoking history of 10 pack years or less
- ECOG performance status 0-2
- Age 18 years or older
- Adequate blood counts and organ function within 14 days prior to registration
- HIV patients on effective therapy with undetectable viral load within 6 months
- Negative pregnancy test for women of childbearing potential within 14 days
- Informed consent provided prior to study entry
You will not qualify if you...
- Recurrent disease
- Evidence of metastatic disease or adenopathy below the clavicles
- Cancers originating from oral cavity site, even if p16 positive
- Simultaneous primary cancers or separate bilateral primary tumors except bilateral tonsil cancers
- Prior invasive malignancy unless disease free for at least 3 years
- Prior systemic chemotherapy or immunotherapy
- Prior radiotherapy overlapping study radiation fields
- Severe active co-morbidities like unstable angina or recent congestive heart failure requiring hospitalization
- Systemic steroid or immunosuppressive treatment within 14 days of registration
- Active autoimmune disease requiring systemic treatment
- Pregnancy, nursing, or planning to conceive or father children
- Allergy to cisplatin, carboplatin, or paclitaxel
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants undergo external beam radiotherapy daily for 5 days a week for 4 weeks and receive chemotherapy with cisplatin weekly or every 3 weeks or carboplatin/paclitaxel weekly as decided by their physician. Blood samples are collected for circulating tumor DNA testing at week 4.
Weekly visits during treatment
Duration - 5 to 7 weeks depending on response
Based on circulating tumor DNA results, participants receive one of two treatment regimens: Participants with a reduction > 95% continue external beam radiotherapy once daily for 5 days a week for 5 weeks with chemotherapy as before; participants without this reduction receive external beam radiotherapy daily for 5 days a week for 7 weeks with chemotherapy as before. Blood samples and PET/CT scans are collected throughout this period.
Weekly visits during adaptive treatment
Duration - Up to 24 months
After completing treatment, participants are followed every 3 months for up to 24 months to monitor their health and any long-term effects.
Visits every 3 months
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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