Phase III Randomized, Controlled Trial of Erlotinib (Tarceva) as Maintenance Therapy in Patients With Squamous Cell Carcinoma of the Head and Neck Treated With Resection and Radiotherapy With or Without Concomitant Chemotherapy With Curative Aim
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 94
- 主要终点
- Number of Participants With Disease Progression
研究概览
简要总结
This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo in participants with resected head and neck squamous cell cancer who are receiving concurrent chemoradiotherapy or radiotherapy alone. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo for 1 year until disease progression or unacceptable 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
- •Adults greater than or equal to (≥) 18 years of age
- •Curatively treated head and neck squamous cell cancer with T3-T4 and/or N2-N3 pathology, with or without other findings of poor prognosis such as extranodal extension, positive resection margins, and perineural or vascular involvement
- •Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
排除标准
- •Macroscopic residual disease after surgery
- •Previous treatment with anti-epidermal growth factor receptor (anti-EGFR) targeted therapies
研究组 & 干预措施
Erlotinib
Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive erlotinib tablets as 150 mg PO daily for 1 year until disease progression or intolerable toxicity.
干预措施: Erlotinib (Drug)
Erlotinib
Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive erlotinib tablets as 150 mg PO daily for 1 year until disease progression or intolerable toxicity.
干预措施: Standard of care (Other)
Placebo
Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive placebo treatment for 1 year until disease progression or intolerable toxicity.
干预措施: Placebo (Drug)
Placebo
Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive placebo treatment for 1 year until disease progression or intolerable toxicity.
干预措施: Standard of care (Other)
结局指标
主要结局
Number of Participants With Disease Progression
时间窗: From inclusion in the study until disease progression (maximum up to 3 years overall)
Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The number of participants who experienced disease progression was reported.
Time to Progression (TTP)
时间窗: From inclusion in the study until disease progression, appearance of second tumor, or death from any cause (maximum up to 3 years overall)
Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. TTP was defined as the time from inclusion in the study to the time of disease progression, appearance of second tumor, or death from any cause, whichever occurred first. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The median duration of TTP and corresponding 95% confidence interval (CI) were to be estimated by Kaplan-Meier analysis and expressed in months.
次要结局
- Number of Participants Who Died(From inclusion in the study until death from any cause (maximum up to 3 years overall))
- Overall Survival (OS)(From inclusion in the study until death from any cause (maximum up to 3 years overall))