Lattice Radiotherapy + Chemo-Immunotherapy for Oral Cancer

Overseen By Colin Hill, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NYU Langone Health

Must not be taking: Cisplatin

Disqualifiers: Oropharynx cancer, Distant metastasis, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Colin Hill, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults with non-metastatic, resectable oral cavity squamous cell carcinoma. Participants must have a good performance status, adequate kidney function, and tumors or lymph nodes ≥3 cm. Men and women of childbearing potential must agree to use contraception. Exclusion criteria are not specified but typically include factors that could affect safety or results.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

My condition can be treated with surgery.

My primary tumor or lymph node is at least 3 cm in size.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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 to identify the maximum tolerated dose (MTD)

6-8 weeks

Expansion

Additional enrolment at the selected maximum tolerated dose (MTD) with chemo-immunotherapy

6-8 weeks

Surgery and Adjuvant Therapy

Surgery occurs 6-8 weeks after radiotherapy; adjuvant therapy is pathology-driven

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Chemotherapy
• Lattice Radiotherapy (LRT)

Trial Overview

The study tests Lattice Radiotherapy (LRT) combined with chemotherapy in two parts: dose-finding to determine the safest radiation dose and expansion at this dose for more patients. The treatment targets either just the primary tumor or both the tumor and involved nodes, followed by surgery.

How Is the Trial Designed?

Group I: Part 2 - Expansion Experimental Treatment 2 Interventions

All Part 2 subjects receive the MTD together with chemo-immunotherapy.

Group II: Part 1 - Dose-Escalation Experimental Treatment 2 Interventions

Treatment starts at dose level 2 (9 Gy × 3 lattice fractions). A single "sentinel" patient is treated first; if no dose-limiting toxicity (DLT) occurs, the trial continues in fixed three-patient cohorts. The Bayesian Optimal Interval (BOIN) algorithm, set to a target DLT rate of 20%, governs escalation or de-escalation among the three prespecified dose levels (8, 9 and 10 Gy × 3). The principal objective of Part 1 is to identify the maximum tolerated dose (MTD).

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+