Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Heath Skinner
Study ID
NCT05388773
Phase
PHASE2
Status
Recruiting
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Conditions

  • Oropharynx Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • therapeutic conventional surgery — PROCEDURE
    Transoral surgical resection of tumor(s).
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • quality-of-life assessment — OTHER
    Ancillary studies.
  • intensity-modulated radiation therapy — RADIATION
    Low-dose IMRT
  • Cisplatin — DRUG
    Given IV.
  • Carboplatin — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Jul 20, 2022
Status verified
Jun 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Brieana Marino, MS
[email protected]
412-647-8258
Samantha Demko, RN, BSN
[email protected]
412-623-1400
Heath D Skinner, MD, PhD (PRINCIPAL_INVESTIGATOR)
Umamaheswar Duvvuri, MD, PhD (SUB_INVESTIGATOR)
Dan Zandberg, MD (SUB_INVESTIGATOR)
Simon Chiosea, MD (SUB_INVESTIGATOR)
Robert L Ferris, MD, PhD (SUB_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

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