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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Overall Response Rate

Secondary outcome measures

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

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

~1940

Carboplatin

2014

Completed Phase 3

~6670

Paclitaxel

2011

Completed Phase 4

~5380

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

351 Previous Clinical Trials

88,292 Total Patients Enrolled

GlaxoSmithKlineIndustry Sponsor

4,753 Previous Clinical Trials

8,069,418 Total Patients Enrolled

Jared Weiss, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

16 Previous Clinical Trials

495 Total Patients Enrolled

Media Library

Bilateral Radiation Clinical Trial Eligibility Overview. Trial Name: NCT01612351 — Phase 2

Head and Neck Cancers Research Study Groups: Non-Randomized Single-Arm

Head and Neck Cancers Clinical Trial 2023: Bilateral Radiation Highlights & Side Effects. Trial Name: NCT01612351 — Phase 2

Bilateral Radiation 2023 Treatment Timeline for Medical Study. Trial Name: NCT01612351 — Phase 2

Frequently Asked Questions

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

When is Transoral Surgery the best medical solution?

"Transoral Surgery is most often used to treat advanced endometrial cancer, but it has also been shown to be effective in managing melanoma, neoplasm metastasis, lymphoma, and non-hodgkin."

Answered by AI

Are we still able to enroll people in this experiment?

"This study, according to the latest information on clinicaltrials.gov, is not presently recruiting patients for participation. The trial was initially posted on 6/1/2012 and was last updated on 4/22/2022. There are presently 4715 other clinical trials searching for patients."

Answered by AI

Are there any risks associated with Transoral Surgery?

"Transoral Surgery received a 2 because while there is data supporting its safety, there are no clinical studies demonstrating Transoral Surgery's efficacy."

Answered by AI

How many people are included in the research project?

"Unfortunately, this particular study is not currently enrolling new patients. The trial was first posted on June 1st, 2012 and most recently updated on April 22nd, 2022. However, there are over 3000 other trials actively recruiting patients with carcinoma, squamous cell and 1600+ trials for Transoral Surgery that may be of interest."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multimodality Risk Adapted Tx Including Induction Chemo for SCCHN Amenable to Transoral Surgery

2012. "Multimodality Risk Adapted Tx Including Induction Chemo for SCCHN Amenable to Transoral Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01612351.

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