RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment
A Phase II Study of RAD001 (Everolimus) in Patients With Fluoropyrimidine and Platinum-refractory Advanced Gastric Cancer
This is a phase II study to evaluate RAD001 (Everolimus) in terms of 4-month progression-free survival rate (primary end-point) and response rate, toxicity, and overall survival (secondary end-points) in patients with metastatic and/or advanced inoperable gastric cancer.
Eligibility criteria include histologically proven gastric/gastroesophageal junction cancer who failed previous first-line standard treatment with fluoropyrimidine and platinum-based chemotherapy.
Oral RAD001 (everolimus) 10mg daily will be administered and the dose will be adjusted according to the observed clinical toxicities. Treatment will be continued until disease progression or patient's intolerability to the study drug.
Total of 54 patients will be enrolled to decide whether the proportion of patients who are free from progression at 4 months (16 weeks), P, is less that or equal to 0.15 or greater than or equal to 0.30 to assess the treatment outcome in 48 patients assuming drop-out rate, 10%.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
Songpa
-
Seoul、Songpa、大韩民国、138-736
- Asan Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients must have histologically or cytologically documented stomach adenocarcinoma including adenocarcinoma of the esophagogastric junction
- Patients must have non-resectable disease by metastasis or recurrent disease after curative surgical resection with uni-dimensionally measurable disease (at least longest diameter 1 cm on computed tomography scan, or at least 2 cm on chest x-ray or physical examination)
- Patients tumor should have failure of 1st line chemotherapy including fluoropyrimidine (5-FU, capecitabine, doxifluridine, S1, or UFT) and platinum (cisplatin, carboplatin, or oxaliplatin) in palliative setting; progression during or within 6 months after chemotherapy
- Age 18 to 75 years old
- Estimated life expectancy of more than 3 months
- ECOG performance status of 2 or lower
- Adequate bone marrow function
- Adequate kidney function
- Adequate liver function
- No prior radiation therapy to more than 25 percent of BM
- Patients must not have psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with this study
- Women of childbearing potential must have a negative pregnancy test on admission
- The patient must be able to understand the study and has given written informed consent to participate in the study
Exclusion Criteria:
- Other tumor types than adenocarcinoma
- Central nervous system metastases or prior radiation for CNS metastasis
- Gastric outlet obstruction or intestinal obstruction
- Evidence of active gastrointestinal bleeding
- Bony metastasis as the sole evaluable disease
- Past or concurrent history of neoplasm other than stomach cancer
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Thyroid disease
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：1
Treatment Arm (RAD001)
|
RAD001 (everolimus) 10mg daily administration orally until disease progression and/or intolerability
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-free Survival Rate at 4-month (16 Weeks)
大体时间：4 months (16 weeks)
|
progression is definced as a more than 20% increase in one or more lesions or the appearance of any new lesion
|
4 months (16 weeks)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
总生存期
大体时间：1年
|
1年
|
|
|
Response Rate
大体时间：2years
|
Tumor response is evaluated according to the new guidelines by RECIST criteria (See Appendix D).
A complete response (CR) is defined as the disappearance of all evidence of cancer for 4 weeks or longer.
A partial response (PR) is defined as a 30% or more reduction in the sum of the longest diameters of target lesions for 4 weeks or longer without any evidence of new lesions or progression of any lesions.
Stable disease is defined as less than a 30% reduction or less than a 20% increase in the longest diameters of target lesions without any evidence of new lesions.
Progressive disease is defined as a more than 20% increase in one or more lesions or the appearance of any new lesion.
|
2years
|
|
Number of Participants With Adverse Events
大体时间：up to 24 weeks
|
(according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0)
|
up to 24 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.