Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06005324
Phase
PHASE1
Status
Recruiting
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Conditions

  • HPV-Negative Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    Given as part of induction chemotherapy.
  • Carboplatin — DRUG
    Given as part of induction chemotherapy.
  • Cetuximab — DRUG
    Given as part of induction chemotherapy.
  • Standard Dose Radiation — RADIATION
    Radiation given once daily for 5 days for 7 weeks as part of CRT regimen.
  • Low Dose Radiation — RADIATION
    Radiation given once daily for 5 days for 6.5 weeks as part of CRT regimen.
  • Cisplatin — DRUG
    Given as part of CRT regimen (7 weekly doses). Investigator will choose the appropriate chemotherapy backbone to be given during CRT.
  • TFHX Regimen — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 18, 2023
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Induction Treatment Arm
    All participants will receive 3 cycles (9 weeks) of chemotherapy with paclitaxel, carboplatin, and cetuximab.
  • Experimental: De-Escalation CRT Cohort
    After completing induction chemotherapy, participants that have significant disease response by imaging will receive low dose radiation treatment with additional chemotherapy (CRT). Investigator will choose the appropriate chemotherapy backbone to be given during CRT.
  • Active Comparator: Standard Treatment Cohort
    After completing induction chemotherapy, participants that have limited disease response by imaging will receive standard dose radiation treatment with additional chemotherapy (CRT). Investigator will choose the appropriate chemotherapy backbone to be given during CRT.

Primary Outcome Measure

Percentage of participants that complete study treatment and provide all required research blood draws. [ Time Frame: To be measured at end of treatment period (9 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637
Clinical Trials Intake
[email protected]
855-702-8222

Find similar trials in Chicago, IL

By research site
University of Chicago Medicine Comprehensive Cancer Center· Chicago, IL

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