Recruiting
Phase 2

Surgical Resection with IMRT

Sponsor:

Heath Skinner

Code:

NCT05388773

Conditions

Oropharynx Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

therapeutic conventional surgery

laboratory biomarker analysis

quality-of-life assessment

intensity-modulated radiation therapy

Cisplatin

Study Details

Brief summary:

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

Oropharynx Cancer

Study ID

NCT05388773

Start date

Jul 20, 2022

Status verified date

Jul, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ECOG performance status of 0 or 1 or Karnofsky score 80-100.
  • Preference is to register patients prior to surgery. However, if not registered prior to surgery, the patient can be registered prior to adjuvant therapy.
  • Patients must have newly diagnosed, histologically or cytologically confirmed SCC or undifferentiated carcinoma of the oropharynx. Patients must have been determined to have resectable oropharyngeal disease. Patients with primary tumor or nodal metastasis fixed to the carotid artery, skull base or cervical spine are not eligible.
  • Patients must be deemed eligible for a TOS procedure with no evidence of distant metastasis as determined by imaging studies. Metastatic disease may be evaluated using CT or PET/CT where appropriate; this can be performed with or without contrast. The following imaging is acceptable to evaluate the primary and regional disease:

  • CT Neck (with contrast preferred but not required)
  • PET/CT
  • MRI Neck (contrast preferred but not required)
  • Patients must have biopsy-proven p16+ oropharynx cancer; the histologic evidence of invasive squamous cell carcinoma may have been obtained from the primary tumor or metastatic lymph node. It is required that patients have a positive p16 IHC (as surrogate for HPV) status from either the primary tumor or metastatic lymph node.
  • Carcinoma of the oropharynx associated with HPV as determined by p16 protein expression using immunohistochemistry (IHC) performed by a CLIA approved laboratory. Using p16 antibody obtained from Roche mtm laboratories AG (CINtec, clone E6H4) is recommended.
  • No prior radiation above the clavicles.
  • Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix, melanoma in-situ (if fully resected), and/or non- melanomatous skin cancer.
  • Patients with the following within the last 6 months prior to registration must be evaluated by a cardiologist and/or neurologist prior to entry into the study.

  • Congestive heart failure > NYHA Class II
  • CVA/TIA
  • Unstable angina
  • Myocardial infarction (with or without ST elevation)
  • Patients must have acceptable renal and hepatic function within 4 weeks prior to registration

o For patients stratified following surgery and to concurrent chemotherapy (Arm CRT), calculated creatinine clearance must be > 60 ml/min using the Cockcroft-Gault formula
  • In patients with a contraindication to cisplatin, carboplatin can be used at time of patient enrollment if they are allocated to ARM CRT.

Exclusion Criteria:

  • No evidence of extensive or "matted/fixed" pathologic adenopathy on preoperative imaging.
  • Patients must not need a microvascular (free flap) reconstruction. Women must not be pregnant or breast-feeding due to the teratogenicity of chemotherapy. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Patient must not have an intercurrent illness likely to interfere with protocol therapy or prevent surgical resection
  • Patients must not have uncontrolled diabetes, uncontrolled infection despite antibiotics, or uncontrolled hypertension within 30 days prior to registration.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm S (Low Risk)

Low risk patients are defined as T1-T2 AND 0 or 1 metastatic lymph nodes AND <3 cm AND clear (≥3mm) margins AND no extracapsular extension (ECE) AND no perineural invasion AND no lymphovascular invasion.

Patients will undergo transoral surgical resection of the oropharyngeal tumor.

experimental: Arm RT (Intermediate Risk)

Intermediate risk patients are defined as having any of the following features: One or more close (<3mm) margins, OR "minimal" ≤1 mm ECE OR 1 or more metastatic lymph nodes >3 cm in diameter OR 2-4 lymph nodes positive (≤ 6 cm in diameter), OR perineural invasion OR lymphovascular invasion

Patients will undergo transoral surgical resection of the oropharyngeal tumor. Following surgery, patients will receive low-dose IMRT five times a week for 3 weeks.

experimental: Arm CRT (High Risk)

High risk patients are defined as having any of the following features: One or more positive margins OR >1 mm ECE OR ≥ 5 metastatic lymph nodes.

Patients will undergo transoral surgical resection of the oropharyngeal tumor. Following surgery, patients will receive low-dose IMRT six times a week and a weekly chemotherapy infusion (cisplatin or carboplatin) during radiation therapy.

Patients will receive 2 Gy/fraction, 6 fractions per week with at least a 6-hour interfraction interval between each treatment:

  • PTV-P50 or PTV-N50: 50 Gy in 25 fractions (2 Gy/fx)
  • PTV-N45: 45 Gy in 25 fractions (1.8 Gy/fx) with simultaneous integrated boost to the PTV-P50 volume.
  • PTV-P30 or PTV-N30: 30 Gy in 15 fractions (2 Gy/fx)

Interventions

therapeutic conventional surgery

Transoral surgical resection of tumor(s).

laboratory biomarker analysis

Correlative studies

quality-of-life assessment

Ancillary studies.

intensity-modulated radiation therapy

Low-dose IMRT

Cisplatin

Given IV.

Carboplatin

Given IV

Primary outcome measure

  • Recurrence-Free Survival (RFS) [ Time Frame: Up to 2 years (for cohort) ]

Central Contacts and Locations

Central contacts

Brieana Marino, MS

412-647-8258rowlesbm@upmc.edu

Samantha Demko, RN, BSN

412-623-1400albesl@upmc.edu

Locations

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Brieana Marino, MS

412-647-8258rowlesbm@upmc.edu

Samantha Demko, RN, BSN

412-623-1400albesl@upmc.edu

Principal Investigator:

Heath D Skinner, MD, PhD

More Information

Sponsor

Heath Skinner

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Papillomavirus Infections
  • Carcinoma, Squamous Cell
  • Oropharyngeal Neoplasms
  • Papilloma
  • Neoplasms, Glandular and Epithelial
  • Pharyngeal Neoplasms
  • Otorhinolaryngologic Neoplasms
  • Head and Neck Neoplasms
  • Pharyngeal Diseases
  • Stomatognathic Diseases
  • Otorhinolaryngologic Diseases
  • DNA Virus Infections
  • Tumor Virus Infections
  • Antineoplastic Agents
  • Intensity Modulated Radiotherapy
  • Carboplatin
  • Cisplatin
  • Transoral Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Heath Skinner on 2026-07-21.