Actively Recruiting
Using CircuLating Tumor DNA to Risk Adapt Post-Operative Therapy for HPV-associated Oropharyngeal Cancer
Led by Zachary Zumsteg · Updated on 2026-05-08
50
Participants Needed
4
Research Sites
368 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single institution phase II study that will enroll patients with T0-3N0-2 p16-positive oropharyngeal squamous cell carcinoma (OSCC) undergoing resection of all gross visible disease at the primary site and in the lymph nodes.
CONDITIONS
Official Title
Using CircuLating Tumor DNA to Risk Adapt Post-Operative Therapy for HPV-associated Oropharyngeal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with T0-3N0-2 p16-positive oropharyngeal squamous cell carcinoma or squamous cell carcinoma of unknown primary involving cervical lymph nodes
- For T0 tumors, at least one metastatic lymph node in cervical level II
- Tumor positive for p16 by immunohistochemistry or high-risk HPV by in-situ hybridization
- Undergoing or have undergone gross total resection of all known disease in head and neck via transoral robotic surgery or acceptable non-robotic surgery with negative margins
- Undergoing or have undergone neck dissection
- Have one or more of the following after surgery: pathologic stage T3, two or more positive lymph nodes, lymph node larger than 3 cm, contralateral lymph node involvement, lymphovascular invasion, perineural invasion, extranodal extension, or close/positive surgical margins
- Detectable circulating tumor DNA (cTTMV-HPV DNA) preoperatively or postoperatively confirmed in tumor tissue
- Age 18 years or older
- ECOG performance status 0 to 2 within 56 days before chemoradiation
- Women of childbearing potential must have negative pregnancy test within 28 days before chemoradiation
- Able to provide informed consent and comply with study requirements
- Adequate blood counts and kidney function within 56 days before chemoradiation
You will not qualify if you...
- Diagnosed with pT4 or cN3 disease
- Evidence of distant metastasis by imaging or clinical exam
- Recurrent disease
- Unable to achieve complete surgical removal of visible tumor
- More than 56 days after surgical removal of primary tumor
- Prior radiation to head and neck exceeding 30 Gy
- Prior active invasive cancer (except certain low-risk cancers) within 2 years
- Severe active heart conditions or recent heart attack
- Active severe infection requiring intravenous antibiotics
- Liver failure causing jaundice or blood clotting problems
- Moderate to severe hearing loss
- Active connective tissue disease needing immunosuppression
- Pregnant or breastfeeding
- Previous allergic reaction to cisplatin
- Received live vaccines within 30 days before starting chemoradiation
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Cedars-Sinai Cancer at Beverly Hills (THO)
Beverly Hills, California, United States, 90211
Actively Recruiting
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
CS Cancer at Valley Oncology Medical Group
Tarzana, California, United States, 91356
Actively Recruiting
4
CS Cancer at the Hunt Cancer Center
Torrance, California, United States, 90505
Actively Recruiting
Research Team
C
Clinical Trial Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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