Multimodality Therapy for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Jared Weiss, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: UNC Lineberger Comprehensive Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see if a three method risk adapted design using induction chemotherapy, transoral surgery and radiation chemotherapy will lessen toxic effects and make treatment of squamous cell carcinoma of the head and neck (SCCHN) better.

Research Team

Jared Weiss, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

Adults over 18 with previously untreated squamous cell carcinoma in the oral cavity, oropharynx, or larynx that can be removed by transoral surgery. Participants must have good liver and kidney function, acceptable blood counts, normal heart function, and agree to use contraception. Excluded are those with metastatic disease, recent major surgery recovery issues, serious infections or conditions that could risk safety or trial goals.

Inclusion Criteria

My heart's pumping ability is within the normal range.

I agree to use birth control during the study.

I am 18 years old or older.

Exclusion Criteria

My cancer has spread to other parts of my body.

I am not a candidate for the chemotherapy drugs in the initial treatment plan.

My cancer is in an early stage and has not spread to lymph nodes.

Treatment Details

Interventions

• Bilateral Radiation (Radiation)
• Cisplatin (Alkylating agents)
• Ipsilateral Radiation (Radiation)
• Lapatinib (Tyrosine Kinase Inhibitor)
• Paclitaxel (Taxane)
• Transoral Surgery (Procedure)

Trial Overview The study tests a combination of treatments for head and neck cancer: starting with chemotherapy drugs (Cisplatin/Carboplatin/Paclitaxel), followed by minimally invasive mouth/throat surgery and radiation therapy (Ipsilateral/Bilateral Radiation). Some may receive Lapatinib. The goal is to reduce side effects while improving treatment outcomes.

Participant Groups

Group I: Non-Randomized Single-Arm Experimental Treatment 7 Interventions

All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Dr. Shelley Earp

UNC Lineberger Comprehensive Cancer Center

Chief Medical Officer since 2018

MD from Johns Hopkins Medical School

Dr. Robert L. Ferris

UNC Lineberger Comprehensive Cancer Center

Chief Executive Officer

PhD in Immunology and MD from Johns Hopkins Medical School; Bachelor's in Chemistry from UNC-Chapel Hill

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

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Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School