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

Summary

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.

Conditions

• Head and Neck Cancer
• Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Carboplatin

Weekly carboplatin given intravenously for 6 weeks during induction chemotherapy.

DRUG

Paclitaxel

Weekly paclitaxel given intravenously prior to carboplatin infusion for 6 weeks during induction chemotherapy.

DRUG

Lapatinib

Lapatinib (1000mg) taken by mouth once a day either one hour before or one hour after a meal for 6 weeks during induction chemotherapy. Participants deemed high risk following transoral surgery will additionally take lapatinib daily concurrently with their chemoradiation therapy.

DRUG

Cisplatin

Weekly cisplatin given intravenously for 6 weeks concurrent with ipsilateral radiation. Alternative regimens may be substituted for cisplatin in patients who are not candidates for cisplatin at the discretion of the investigator. If carboplatin is used, a maximum of 125 mL/min must be used, as per standard of care.

DRUG

Cisplatin

Cisplatin given once every 3 week cycle intravenously for 5-7 weeks concurrent with bilateral radiation and daily lapatinib. Alternative regimens may be substituted for cisplatin in patients who are not candidates for cisplatin at the discretion of the investigator. If carboplatin is used, a maximum of 125 mL/min must be used, as per standard of care.

RADIATION

Ipsilateral Radiation

After transoral surgery, subjects deemed medium risk will receive ipsilateral radiation as per standard of care 5 days/week for 6 weeks concurrent with weekly cisplatin.

RADIATION

Bilateral Radiation

After transoral surgery, subjects deemed high risk will receive bilateral radiation as per standard of care 5 days/week for 5-7 weeks concurrent with cisplatin every 3 weeks and daily lapatinib.

PROCEDURE

Transoral Surgery

Transoral resection by robotic or microscopic approach, which will be at the discretion of the treating surgeon.

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

• UNC Lineberger Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Jared Weiss, MD · University of North Carolina, Chapel Hill

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2016-11-30

Completion

2025-05-19

Countries

• United States

Study Locations