Actively Recruiting
Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer
Led by Heath Skinner · Updated on 2025-06-19
150
Participants Needed
1
Research Sites
440 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a trial studying patients with human papilloma virus (HPV) positive oropharyngeal cancer with tumors that can be removed via transoral surgery. Following surgery, patients will be classified as either low, intermediate, or high risk based on the characteristics of the tumors. Low risk patients (Arm S) will receive no further treatment after surgery. Intermediate risk patients (Arm RT) will be treated with Intensity Modulated Radiotherapy (IMRT) after surgery. High risk patients (Arm CRT) will receive a combination of IMRT and chemotherapy after surgery. Patients will be followed for up to five years after the completion of treatment.
CONDITIONS
Official Title
Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status of 0 or 1 or Karnofsky score 80-100
- Newly diagnosed, histologically or cytologically confirmed squamous cell carcinoma or undifferentiated carcinoma of the oropharynx
- Resectable oropharyngeal disease suitable for transoral surgery
- No evidence of distant metastasis as determined by imaging (CT neck, PET/CT, or MRI neck)
- Biopsy-proven p16-positive oropharynx cancer confirmed by immunohistochemistry
- No prior radiation therapy above the clavicles
- Disease-free for at least two years if previously treated for a malignancy, except certain in situ cancers
- Evaluation by cardiologist/neurologist within 6 months if history of congestive heart failure (NYHA > Class II), stroke/TIA, unstable angina, or myocardial infarction
- Acceptable renal and hepatic function within 4 weeks prior to registration
- Creatinine clearance > 60 ml/min for patients receiving chemotherapy
- Use of carboplatin allowed if cisplatin contraindicated
You will not qualify if you...
- Presence of extensive or fixed pathologic lymph nodes on preoperative imaging
- Need for microvascular free flap reconstruction
- Pregnant or breastfeeding women
- Female participants of childbearing potential not confirmed negative for pregnancy within 2 weeks prior to registration
- Intercurrent illness likely to interfere with treatment or surgery
- Uncontrolled diabetes, infection, or hypertension within 30 days prior to registration
AI-Screening
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Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
B
Brieana Marino, MS
CONTACT
S
Samantha Demko, RN, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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