TRYHARD: A Phase II, Randomized, Double Blind, Placebo-Controlled Study of Lapatinib (Tykerb®) for Non-HPV Locally Advanced Head and Neck Cancer With Concurrent Chemoradiation
Overview
- Phase
- Phase 2
- Intervention
- IMRT
- Conditions
- Non-HPV Locally Advanced Head and Neck Cancer
- Sponsor
- Radiation Therapy Oncology Group
- Enrollment
- 142
- Locations
- 16
- Primary Endpoint
- Percentage of Participants Alive Without Progression (Progression-free Survival)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
IMRT + cisplatin + placebo
Intensity Modulated Radiation Therapy (IMRT) with cisplatin and placebo
Intervention: IMRT
IMRT + cisplatin + placebo
Intensity Modulated Radiation Therapy (IMRT) with cisplatin and placebo
Intervention: Cisplatin
IMRT + cisplatin + placebo
Intensity Modulated Radiation Therapy (IMRT) with cisplatin and placebo
Intervention: placebo
IMRT + cisplatin + lapatinib
IMRT with cisplatin and lapatinib
Intervention: IMRT
IMRT + cisplatin + lapatinib
IMRT with cisplatin and lapatinib
Intervention: Cisplatin
IMRT + cisplatin + lapatinib
IMRT with cisplatin and lapatinib
Intervention: Lapatinib
Outcomes
Primary Outcomes
Percentage of Participants Alive Without Progression (Progression-free Survival)
Time Frame: 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 Outcomes
- 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.)
- Percentage of Participants With Local-regional Progression(From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.)
- 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.)
- 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.)
- 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).)