RecruitingPhase 1NCT06005324

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


Sponsor

University of Chicago

Enrollment

36 participants

Start Date

Dec 18, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized, adaptive approach to treating advanced head and neck cancer (HPV-negative) with radiation and chemotherapy — adjusting the treatment plan based on how the tumor responds during therapy. **You may be eligible if:** - You are 18 or older - You have been diagnosed with locally advanced head and neck cancer (stage III or IV) that is HPV-negative - Your cancer is in the oral cavity, throat, voice box, nasal sinuses, or nearby areas - You have not previously had radiation or chemotherapy for head and neck cancer - Your organs (blood, kidney, liver) are working well enough to tolerate treatment **You may NOT be eligible if:** - Your cancer has spread to distant parts of the body - You have HIV, active hepatitis B/C, or active tuberculosis - You have received other immune-suppressing treatments recently - You are pregnant or breastfeeding - You received a live vaccine within 28 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaclitaxel

Given as part of induction chemotherapy.

DRUGCarboplatin

Given as part of induction chemotherapy.

DRUGCetuximab

Given as part of induction chemotherapy.

RADIATIONStandard Dose Radiation

Radiation given once daily for 5 days for 7 weeks as part of CRT regimen.

RADIATIONLow Dose Radiation

Radiation given once daily for 5 days for 6.5 weeks as part of CRT regimen.

DRUGCisplatin

Given as part of CRT regimen (7 weekly doses). Investigator will choose the appropriate chemotherapy backbone to be given during CRT.

DRUGTFHX 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.


Locations(1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

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NCT06005324


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