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Multimodality Therapy for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Jared Weiss, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Left ventricular ejection fraction (LVEF) must be > the lower limit of normal (LLN) per institutional standards by either echocardiography or radionuclide-based multiple gated acquisition (MUGA)

All males and females of childbearing potential must agree to use adequate contraception during the study. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy

Must not have

Any metastatic disease

Not considered eligible for any of the chemotherapy agents included in the induction regimen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new, less toxic treatment for head and neck cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include nausea from chemotherapy; surgical complications like bleeding or infection; radiation-induced skin irritation; fatigue; allergic reactions to drugs used; heart problems due to Lapatinib; decreased white blood cells leading to higher infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I agree to use birth control during the study.

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I am 18 years old or older.

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My blood tests show I have enough white blood cells, hemoglobin, and platelets.

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My liver and kidney functions are within normal ranges.

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I have a type of throat cancer that has not been treated and can be approached through the mouth.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to other parts of my body.

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

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

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I had major surgery less than 3 weeks ago and haven't fully recovered.

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I am not taking any medication that is not allowed with lapatinib treatment.

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I do not have any serious infections, heart problems, or mental health conditions that could put me at risk.

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I am not pregnant or breastfeeding and agree to use contraception during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate

Secondary study objectives

Estimate the Pathologic Complete Response Rate at the Primary Site and in the Neck Following Induction Chemotherapy

Feasibility of 3 Part Therapy

Number of Patients Who Decreased in Risk Level Post Induction Chemotherapy.

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Non-Randomized Single-ArmExperimental Treatment7 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lapatinib

2006

Completed Phase 3

~3530

Cisplatin

2013

Completed Phase 3

~3120