NCT06005324

Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer

Pilot Study of Induction Therapy Followed by Response-adaptive Treatment and Dynamic Changes in Circulating Tumor DNA in Locoregionally Advanced HPV Negative Head and Neck Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial will assess whether or not blood based biomarker testing can be used to personalize cancer treatment for patients with locally advanced head and neck cancer.

Conditions

• HPV-Negative Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Paclitaxel	Given as part of induction chemotherapy.
DRUG	Carboplatin	Given as part of induction chemotherapy.
DRUG	Cetuximab	Given as part of induction chemotherapy.
RADIATION	Standard Dose Radiation	Radiation given once daily for 5 days for 7 weeks as part of CRT regimen.
RADIATION	Low Dose Radiation	Radiation given once daily for 5 days for 6.5 weeks as part of CRT regimen.
DRUG	Cisplatin	Given as part of CRT regimen (7 weekly doses). Investigator will choose the appropriate chemotherapy backbone to be given during CRT.
DRUG	TFHX Regimen	Chemotherapy with paclitaxel, fluorouracil (5FU), and hydroxyurea given in combination with radiation therapy. Investigator will choose the appropriate chemotherapy backbone to be given during CRT.

Timeline

• Start date: 2023-12-18
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2023-08-22
• Last updated: 2025-06-08

Locations

1 site across 1 country: United States

Regulatory

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