PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of radiation therapy plus cisplatin in patients who have head and neck cancer that is not related to the human papillomavirus (HPV).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
142
Intensity modulated radiation therapy (IMRT), 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
100 mg/m\^2 administered intravenously on days 8 and 29
1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
University of California, San Diego
La Jolla, California, United States
Percentage of Participants Alive Without Progression (Progression-free Survival)
An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of survival times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided. Analysis occurred after 67 progressions or deaths were reported.
Time frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.
Percentage of Participants Alive (Overall Survival)
An event for overall survival is death due to any cause. Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of survival times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided.
Time frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.
Percentage of Participants With Distant Metastases
Failure for distant metastasis endpoint was defined as distant progression; local-regional failure and death due to any cause were considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided.
Time frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.
Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events
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1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
Sutter General Hospital
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Emory University
Atlanta, Georgia, United States
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
...and 6 more locations
Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event. "Treatment-related" is defined definitely, probably, or possibly related to treatment.
Time frame: From start of treatment to last follow-up. Maximum follow-up at time of analysis was 7.1 years.
Percentage of Participants Who Complied With Protocol Treatment
Compliance with protocol treatment is defined as "per protocol" or "acceptable variation" per study chair review for IMRT, cisplatin, pre-IMRT lapatinib/placebo, concurrent lapatinib/placebo, and maintenance lapatinib/placebo. Rates of treatment compliance were compared between groups by a 2-sided Fisher's exact test.
Time frame: From start of treatment to end of treatment (approximately 5 months from randomization).
Percentage of Participants With Local-regional Progression
Failure for local-regional control endpoint was defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression; distant metastasis and death due to other causes were considered competing risks. Local-regional failure time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Failure rates are estimated by the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided.
Time frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.
Performance Status Scale for Head & Neck Cancer.
Time frame: 3 months, 1 year, and 2 years
Functional Assessment of Cancer Therapy - Head & Neck.
Time frame: 3 months, 1 year, and 2 years.
University of Michigan Xerostomia-Related Quality of Life Scale.
Time frame: 3 months, 1 year, and 2 years.
HER2, EGFR, EMT as Biomarkers of Response.
Time frame: End of Study