TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.
- Conditions
- Non-HPV Locally Advanced Head and Neck Cancer
- Interventions
- Registration Number
- NCT01711658
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 142
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IMRT + cisplatin + lapatinib IMRT IMRT with cisplatin and lapatinib IMRT + cisplatin + placebo IMRT Intensity Modulated Radiation Therapy (IMRT) with cisplatin and placebo IMRT + cisplatin + placebo placebo Intensity Modulated Radiation Therapy (IMRT) with cisplatin and placebo IMRT + cisplatin + lapatinib Lapatinib IMRT with cisplatin and lapatinib IMRT + cisplatin + lapatinib Cisplatin IMRT with cisplatin and lapatinib IMRT + cisplatin + placebo Cisplatin Intensity Modulated Radiation Therapy (IMRT) with cisplatin and placebo
- Primary Outcome Measures
Name Time Method Percentage of Participants Alive Without Progression (Progression-free Survival) From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years. 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events From start of treatment to last follow-up. Maximum follow-up at time of analysis was 7.1 years. 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.
Percentage of Participants With Local-regional Progression From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years. 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.
HER2, EGFR, EMT as Biomarkers of Response. End of Study Percentage of Participants With Distant Metastases From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years. 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.
Performance Status Scale for Head & Neck Cancer. 3 months, 1 year, and 2 years University of Michigan Xerostomia-Related Quality of Life Scale. 3 months, 1 year, and 2 years. Percentage of Participants Alive (Overall Survival) From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years. 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.
Functional Assessment of Cancer Therapy - Head & Neck. 3 months, 1 year, and 2 years. Percentage of Participants Who Complied With Protocol Treatment From start of treatment to end of treatment (approximately 5 months from randomization). 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.
Trial Locations
- Locations (16)
University of California, San Diego
🇺🇸La Jolla, California, United States
Sutter General Hospital
🇺🇸Sacramento, California, United States
McGill Cancer Centre at McGill University
🇨🇦Montreal, Quebec, Canada
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Fox Chase Cancer Center Buckingham
🇺🇸Furlong, Pennsylvania, United States
Yale University
🇺🇸New Haven, Connecticut, United States
James Graham Brown Cancer Center at University of Louisville
🇺🇸Louisville, Kentucky, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
University of Texas Southwestern Medical School
🇺🇸Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States