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Chemotherapy

Personalized Adaptive Therapy for Head and Neck Cancer

Phase 1

Waitlist Available

Led By Ari Rosenberg, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to be measured at 3 months after end of treatment period

Awards & highlights

Study Summary

This trial looks at using blood tests to tailor cancer treatment for head and neck cancer patients. #personalizedmedicine

Who is the study for?

This trial is for adults with locally advanced, non-metastatic head and neck squamous cell carcinoma that's HPV negative. They must have measurable disease, no prior cancer treatments or surgeries (with some exceptions), normal organ function, and agree to contraception if applicable. Excluded are those with certain infections, other cancers needing treatment, significant heart or psychiatric conditions.Check my eligibility

What is being tested?

The study tests if blood biomarker testing can tailor treatment for head and neck cancer patients. It involves chemotherapy drugs like Cisplatin or Carboplatin combined with Paclitaxel and Cetuximab plus radiation therapy at standard or low doses based on the TFHX regimen.See study design

What are the potential side effects?

Possible side effects include allergic reactions to medication components, fatigue from radiation therapy, nausea from chemotherapy drugs like Cisplatin and Carboplatin, skin rash due to Cetuximab, as well as potential impacts on blood counts leading to increased infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to be measured at 3 months after end of treatment period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to be measured at 3 months after end of treatment period

This trial's timeline: 3 weeks for screening, Varies for treatment, and to be measured at 3 months after end of treatment period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine if ctDNA levels is predicative of disease response

Percentage of participants that complete study treatment and provide all required research blood draws.

Secondary outcome measures

Long Term Disease Response based on RECIST 1.1

Number of participants with side effects related to study treatment

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Induction Treatment ArmExperimental Treatment3 Interventions

All participants will receive 3 cycles (9 weeks) of chemotherapy with paclitaxel, carboplatin, and cetuximab.

Group II: De-Escalation CRT CohortExperimental Treatment3 Interventions

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.

Group III: Standard Treatment CohortActive Control3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

Paclitaxel

2011

Completed Phase 4

~5380

Carboplatin

2014

Completed Phase 3

~6670

Cisplatin

2013

Completed Phase 3

~1940

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,002 Previous Clinical Trials

817,814 Total Patients Enrolled

Ari Rosenberg, MDPrincipal InvestigatorUniversity of Chicago

4 Previous Clinical Trials

578 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the Induction Treatment Arm a reliable option for individuals?

"Due to the early stage of research, our team at Power assigned Induction Treatment Arm a score of 1 on the safety scale. This Phase 1 trial only has limited data available regarding both its efficacy and safety."

Answered by AI

Is enrollment in this study still accepting participants?

"The clinicaltrials.gov records reveal that this study, which was first posted on December 1st 2023 and last updated August 16th 2023, is not currently recruiting patients. Nevertheless, there are still 2,678 other studies actively enrolling volunteers at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer

2023. "Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06005324.