HPV-Associated Oropharyngeal Squamous Cell Carcinoma
Conditions
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.
Interventions
RADIATIONShortened Course Adjuvant Radiotherapy Following TORS
Shortened Course Adjuvant Radiotherapy Following TORS
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Locoregional control | 2 years | To determine whether disease recurs locally (at primary site) or in regionally in the nodes of the neck |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2 Years | To determine progression-free survival (any progression) |
| Metastasis-free survival | 2 years | To determine metastasis-free survival (any distant metastasis) |
| Overall survival | 2 years | To determine overall survival (alive or not) |
| Differences in toxicity between patients receiving IMRT and patients receiving PBT | 2 years | To assess toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. |
| Patient-Reported Quality of Life using MDASI-HN | 2 years | The MD Anderson Symptom Inventory - Head \& Neck (MDASI-HN) 1. Minimum Value: 0 2. Maximum Value: 280 3. Higher scores mean worse outcome |
| Patient-Reported Quality of Life using MDADI | 2 years | The MD Anderson Dysphagia Inventory (MDADI) 1. Minimum Value: 20 2. Maximum Value: 100 3. Higher scores mean better outcome |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlexander Lin, MD
University of Pennsylvania
Outcome results
None listed