NCT05544136

A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer

A Pilot Study of Radiation De-Escalation for p16 Negative Oropharyngeal Cancer and p16-Negative or Positive Laryngeal and Hypopharyngeal Cancers

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the treatment approach of de-escalated radiation and chemotherapy followed by a planned neck dissection surgery in people with head and neck cancer. The study will look at how effective the treatment approach is against participants' cancer.

Conditions

• Head and Neck Cancer
• Head and Neck Carcinoma
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	18F-FMISO PET/CT scan	18F-FMISO PET/CT scan (only 1 injection) that occurs 5-10 treatment days after RT start
RADIATION	Chemoradiation therapy	* 18F-FMISO hypoxia negative patients complete CRT with 70Gy primary tumor and 50Gy de-escalated RT dose to gross nodes (if 50Gy is has pilot efficacy, then 44Gy to gross nodes; if 44Gy has pilot efficacy, then 40Gy to gross nodes). * 18F-FMISO hypoxia positive patients are taken off study and complete SOC 70Gy CRT to primary tumor and gross nodes.
DRUG	Carboplatin	The chemotherapy used in this protocol is the standard of care for head and neck cancer, cisplatin or carboplatin/5-Fluorouracil

Timeline

• Start date: 2022-09-12
• Primary completion: 2027-03-12
• Completion: 2027-03-12
• First posted: 2022-09-16
• Last updated: 2026-02-27

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study