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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 16
- 主要终点
- Percentage of Participants Alive Without Progression (Progression-free Survival)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IMRT + cisplatin + placebo
Intensity Modulated Radiation Therapy (IMRT) with cisplatin and placebo
干预措施: IMRT (Radiation)
IMRT + cisplatin + placebo
Intensity Modulated Radiation Therapy (IMRT) with cisplatin and placebo
干预措施: Cisplatin (Drug)
IMRT + cisplatin + placebo
Intensity Modulated Radiation Therapy (IMRT) with cisplatin and placebo
干预措施: placebo (Drug)
IMRT + cisplatin + lapatinib
IMRT with cisplatin and lapatinib
干预措施: IMRT (Radiation)
IMRT + cisplatin + lapatinib
IMRT with cisplatin and lapatinib
干预措施: Cisplatin (Drug)
IMRT + cisplatin + lapatinib
IMRT with cisplatin and lapatinib
干预措施: Lapatinib (Drug)
结局指标
主要结局
Percentage of Participants Alive Without Progression (Progression-free Survival)
时间窗: 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.
次要结局
- 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).)