A Phase 2, Randomized Trial of Chemoradiation With or Without Panitumumab in Subjects With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 153
- 主要终点
- Local Regional Control Rate at 2 Years
研究概览
简要总结
The addition of chemotherapy to radiotherapy (chemoradiation) has improved outcomes for patients with locally advanced squamous cell carcinoma of the head and neck but additional improvements to treatment regimens are needed. The study is investigating if the addition of a targeted therapy (panitumumab) can improve the efficacy of chemoradiation without adding unmanageable toxicity.
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
- None
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
- •Confirmed diagnosis of Stage III or IVa-b (M0) squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (you must be well enough to receive chemoradiation therapy)
- •You must be at least 18 years of age
- •Your test results must show that your kidneys, liver and blood cells are working adequately and that, if you are female, you are not pregnant
- •You must have measurable disease
排除标准
- •Cancer of the nasopharynx, sinus, salivary gland or skin
- •History of another cancer (other than head and neck) unless treated with curative intent and with no evidence of disease for more than 3 years, with the exception of non-melanoma skin cancer or in situ cervical cancer
- •Previous treatment with anti-endothelial growth factor receptor (EGFr) antibody therapy or EGFr inhibitors
- •Previous treatment for head and neck cancer, with chemotherapy, surgery (except nodal sampling or biopsy) or radiotherapy
- •Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within one year before you join the study
- •Chronic obstructive pulmonary disease (pneumonia or respiratory decompensation) resulting in hospitalization within 6 months of study screening
- •History or evidence of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis)
- •Major surgery within 28 days of screening
研究组 & 干预措施
Panitumumab Plus Chemoradiation
Participants received standard radiation therapy for 7 weeks and cisplatin 75 mg/m^2 and panitumumab 9 mg/kg on Days 1, 22 and 43.
干预措施: Cisplatin (Drug)
Panitumumab Plus Chemoradiation
Participants received standard radiation therapy for 7 weeks and cisplatin 75 mg/m^2 and panitumumab 9 mg/kg on Days 1, 22 and 43.
干预措施: Standard Fractionation Radiotherapy (Radiation)
Panitumumab Plus Chemoradiation
Participants received standard radiation therapy for 7 weeks and cisplatin 75 mg/m^2 and panitumumab 9 mg/kg on Days 1, 22 and 43.
干预措施: Panitumumab (Drug)
Chemoradiotherapy Alone
Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
干预措施: Cisplatin (Drug)
Chemoradiotherapy Alone
Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
干预措施: Standard Fractionation Radiotherapy (Radiation)
结局指标
主要结局
Local Regional Control Rate at 2 Years
时间窗: 2 years
In this study participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.
次要结局
- Local Regional Control Rate at 6 Months and 12 Months(6 months and 12 months)
- Duration of Local-regional Control(From first dose up to 37 months)
- Overall Survival(From first dose date up to 37 months)
- Percentage of Participants With an Objective Response at 6 Months(6 months)
- Progression-Free Survival(From first dose date to 37 months)
- Percentage of Participants With a Complete Response at 6 Months(6 months)