Phase IB Trial of Preoperative Lattice-Based Hypofractionated Radiotherapy and Chemo-Immunotherapy for Oral Cavity Squamous Cell Carcinoma
NYU Langone Health
Summary
Single-arm, two-part, phase IB safety study that uses a Bayesian Optimal Interval (BOIN-12) dose-escalation scheme. Part 1 (Dose Finding) - Sentinel start at 9 Gy × 3 followed by fixed 3-patient BOIN cohorts exploring 8 Gy × 3 → 9 Gy × 3 → 10 Gy × 3. Target DLT rate θ = 0.20; ≈ 7-15 participants. Part 2 (Expansion) - Additional enrolment at the selected maximum tolerated dose (MTD) until ≈ 30 evaluable subjects (Parts 1 + 2 combined). Patients receive peaks to the primary tumor alone (Group A) or to the primary + involved nodes (Group B) at the investigators' discretion (non-random). Surgery occurs 6-8 weeks after RT; adjuvant therapy is pathology-driven.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Non-metastatic, pathologically confirmed oral cavity squamous cell carcinoma, cT3-T4a cN0-N3 or cT1-T2 cN1-N3. Histologic variants will be included (papillary squamous cell carcinoma and basaloid squamous cell carcinoma, e.g.). Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oral cavity (oral tongue, floor of mouth, alveolar ridge, buccal or lip, i.e.) * Surgically resectable * Zubrod Performance Status of 0-1 * (Phase I) Primary and lymph node ≥ 3 cm * (Phase II) Primary and lymph node ≥ 3 cm OR…
Interventions
- DrugChemotherapy
Patients receive standard induction chemoimmunotherapy (carboplatin, paclitaxel, and pembrolizumab) in three 21-day cycles, beginning on Day 1.
- RadiationLattice Radiotherapy (LRT)
LRT is administered concurrently with the first cycle of chemoimmunotherapy according to the dose-finding rules
Location
- NYU Langone HealthNew York, New York