Lattice-Based Radiotherapy and Chemo-Immunotherapy for Oral Cavity Squamous Cell Carcinoma (NCT07335380)
Phase IB Trial of Preoperative Lattice-Based Hypofractionated Radiotherapy and Chemo-Immunotherapy for Oral Cavity Squamous Cell Carcinoma
๐ฉบ Plain-English Summary (8th-Grade Level)
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 ร 3 followed by fixed 3-patient BOIN cohorts exploring 8 Gy ร 3 โ 9 Gy ร 3 โ 10 Gy ร 3. Target DLT rate ฮธ = 0.20; โ 7-15 participants. Part 2 (Expansion) - Additional enrolment at the selected maximum tolerated dose (MTD) until โ 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 can join: Review the eligibility criteria below.
Location: NYU Langone Health โ New York, New York
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- NYU Langone Health โ New York, New York
๐ Contact the Study Coordinator
Phone: (212) 731-5003
Email: Colin.Hill@Nyulangone.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Oral Cavity Squamous Cell Carcinoma
- H&N NEO-COMBAT XL: Neoadjuvant XL-092 (Zanzalintinib) and Pembrolizumab (Keytruda) in Surgically Resectable, HPV Negative Oral Cavity Squamous Cell Carcinoma (OCSCC) โ Atlanta, Georgia
- Nisin in Oral Cavity Squamous Cell Carcinoma (OCSCC) โ San Francisco, California
- Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial โ Ann Arbor, Michigan
Explore by condition: All Oral Cavity Squamous Cell Carcinoma clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.