Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery

Conditions

• Neoplasms, Head and Neck

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Lapatinib — DRUG
  Dual ErbB1/2 inhibitor
• Chemoradiation — RADIATION
  Radiation plus platinum based chemotherapy
• Placebo — OTHER
  Placebo

Study Details

This is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial comparing the efficacy of adjuvant oral lapatinib versus placebo in high-risk subjects with head and neck cancer following surgery. Lapatinib or placebo will be administered post-operatively in combination with chemoradiotherapy followed by maintenance with lapatinib or placebo for 1 year. The primary goal is to determine if lapatinib is effective at reducing the recurrence of the disease in these high-risk patients.

Key Dates

Start date

Dec 31, 2006

Status verified

Jun 2014

Primary completion

Mar 31, 2013

Completion

Nov 30, 2013

Study Design

Enrollment

688 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lapatinib+Chemoradiation
  Adjuvant concurrent chemoradiotherapy plus lapatinib 1500 mg once daily for 6 to 7 weeks, followed by lapatinib 1500 mg once daily for one year. Chemoradiotherapy=total dose of 66Gy over 6-7 weeks plus cisplatin 100mg/m2 on days 1,2 and 43 of the course of radiotherapy. Lapatinib is also given at 1500 mg once daily for 3-7 days prior to the start of chemoradiotherapy.
• Placebo Comparator: Placebo+Chemoradiation
  Adjuvant concurrent chemoradiotherapy plus placebo once daily for 6 to 7 weeks, followed by placebo once daily for one year. Chemoradiotherapy = total dose of 66Gy over 6-7 weeks plus cisplatin 100mg/m2 on days 1,2 and 43 of the course of treatment. Placebo is also given once daily for 3-7 days prior to the start of chemoradiotherapy.

Primary Outcome Measure

Disease Free Survival (DFS) [ Time Frame: From randomization until the earliest date of disease recurrence or death due to any cause (average of 101 study weeks) ]

Locations (5)

Find similar trials in Springfield, IL

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