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Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer

NCT06005324 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-06-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Ari Rosenberg, MD · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06005324 on ClinicalTrials.gov