MedTrace Logo

Lapatinib and Radiation for Stage III-IV Head and Neck Cancer Patients Who Cannot Tolerate Concurrent Chemotherapy

NCT00490061 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-03-06

Study results available
· View outcomes & findings →

Summary

We propose to combine lapatinib with RT alone in patients with locally advanced head and neck cancer who cannot tolerate chemotherapy. The main objective of the study is to determine the efficacy of combining concurrent radiation and lapatinib in terms of time-to-progression (TTP) in this group of patients. In addition, we will determine the 2-year locoregional control rate (LRC), progression-free survival (PFS) and overall survival (OS) in these patients. We will also evaluate the profile and frequency of late toxicity, specifically mucosal and dermatologic toxicity, of the combination of lapatinib and RT in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).

Conditions

Interventions

DRUG

Lapatinib

1500 mg po daily orally

PROCEDURE

Radiotherapy (radiation)

Standard of Care

DEVICE

G.E. Healthcare 1.5T MR, systems revision 12.0 M5

Standard of Care, used to deliver IMRT

DEVICE

DCE-MRI

A subset of patients received imaging before and after Lapatinib loading, prior to starting radiotherapy.

Sponsors & Collaborators

Principal Investigators

  • Quynh-Thu Le · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2013-01-31
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00490061 on ClinicalTrials.gov