Clinical trial NCT05714657: Shortened Course Adjuvant Radiotherapy Following TORS
Official title: A Phase II Study of Shortened Course, Dose De-Intensified Adjuvant Radiotherapy Following Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: HPV-Associated Oropharyngeal Squamous Cell Carcinoma
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm, phase II study to establish the safety of reducing radiation dose in selected HPV-Associated OPSCC patients receiving adjuvant radiation after TORS and neck dissection. This protocol also allows for sparing of the primary resection bed, in appropriate patients, as previously published by our group and found to be safe and effective.

Detailed description: This is a single-arm Phase II non-inferiority study of adjuvant radiation for locally-advanced HPV-Associated oropharyngeal squamous cell carcinoma. Patients with pT0-T3, N0-N1, M0 disease (per AJCC 8th Edition), detectable pre-operative and undetectable postoperative ctHPVDNA will be eligible. Patients will have undergone TORS primary site resection and neck dissection. Patients will undergo adjuvant RT +/- guideline-indicated chemotherapy. The neck and the primary site will be considered separately.

The primary objective of the study will be to determine the 2-year locoregional control (LRC) rate. Secondary objectives include measures of toxicity (as measured by CTCAE, version 5.0), patient-reported QOL (as measured by the MDASI and MDADI questionnaire), progression-free survival, metastasis-free survival, and overall survival. Differences between patients treated with IMRT and proton therapy in terms of toxicity and QOL will serve as another secondary objective.

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years old
* Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, p16-positive on immunohistochemistry or HPV-positive by In-Situ Hybridization
* Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 8th Ed)
* Pathologic N0-N1 disease (per AJCC 8th Ed)
* Preoperative plasma ctHPVDNA of ≥ 50 copies/mL
* Undetectable postoperative plasma ctHPVDNA
* ECOG Performance Status 0-1

Exclusion Criteria:

* Prior external beam radiation therapy to the head and neck
* Presence of T4 disease
* ≥ 5 positive lymph nodes (which is pathologic N2 disease, per AJCC 8th edition)
* Presence of distant metastatic disease
* Uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.

Primary outcomes:
measure: Locoregional control
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 2 Years
measure: Metastasis-free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
measure: Dysphagia, as measured by patient-reported outcome
timeFrame: 2 years
measure: Quality of life, as measured by patient-reported outcome
timeFrame: 2 years
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Alexander Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: