Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy (President)
A Phase III Trial of Preoperative or Postoperative Chemoradiation Therapy for Potentially Resectable Adenocarcinoma of Stomach Cancer
研究概览
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Shanxi
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Xi'an、Shanxi、中国、710032
- 主动,不招人
- Xijing Hospital, GI institute
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Sichuan
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Chengdu、Sichuan、中国、610000
- 招聘中
- friendship Hospital
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接触:
- lili deng, MD
- 电话号码:+8613880926676
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Siyang、Sichuan、中国
- 招聘中
- Ziyang People's Hospital
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接触:
- min wei, MD
- 电话号码:+8613980386078
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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 with potentially resectable adenocarcinoma of the stomach with histologic proof.
- EUS or MRI stage T3-4, any N, M0.
- Adequate bone marrow (defined as peripheral absolute granulocyte count of > 2,000/μL, and platelet count of>100,000/μL), liver (bilirubin < 1.5 mg/dl), and renal functions (creatinine < 1.5 mg/dl).
- Absence of peritoneal disease by laparoscopic staging; no positive cytology of pleural, or pericardial effusion.
- No prior major surgery or radiotherapy to the stomach, or immunotherapy or chemotherapy for any reason.
- Patients must have a life expectancy of at least 16 weeks.
- Performance status of < 2 (Zubrod scale).
- No biopsy proof of lymph node metastases outside the study field.
- No evidence of metastatic disease to distant organs.
- No presence of concurrent or previous malignancies < 5 years, other than noninvasive skin cancer.
- No uncontrolled or severe cardiac disease, diabetes or hypertension.
- Signed study-specific consent form prior to study entry.
Exclusion Criteria:
- Evidence of metastatic disease
- Prior chemotherapy or radiotherapy
- Patients with a past history of cancer
- Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled
- Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures
- Cardiac failure or Sever Pulmonary disease
- Patients with impaired gastrointestinal absorption for whatever reason
- Patients medically unfit for cisplatin or taxol chemotherapy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Arm 1 pre-operative chemoradiation
Chemo1 x 2 followed by ChemRT followed by Surgery followed by Chemo2 x 2
|
Chemotherapy 1: First 2 courses of chemotherapy with the Capacitabine /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a one-hour bolus on day1-5. Chemoradiotherapy: At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks. Chemotherapy2: Four to five weeks after chemoradiotherapy, Restaged and surgical resection, a D2 resection is encouraged. Peritoneal cytology will be obtained. The J-tube will be left in for at least 8 weeks after surgery to supplement patient's nutrition. 2nd courses of chemotherapy with the Capacitabine. Capacitabine1 g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29. |
有源比较器:Arm 2 post operative chemoradiation
Surgery followed by Chemo1 x 2 followed by ChemRT followed by Chemo2 x 2
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Surgical resection, a D2 resection is encouraged. Chemotherapy 1: All patients will first receive two courses of chemotherapy with the Capacitabin /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a bolus on day1-5. Chemotherapywill be repeated beginning on Day 22. Chemoradiotherapy: At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks. Chemotherapy2: 2nd courses of chemotherapy with the Capacitabin. Capacitabine 1g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29 |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Progression Free Survival
大体时间:up to 5 year
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up to 5 year
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次要结果测量
结果测量 |
大体时间 |
---|---|
Overall Survival
大体时间:up to 5 year
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up to 5 year
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R0 Resection Rate
大体时间:At time of surgery
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At time of surgery
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合作者和调查者
合作者
调查人员
- 学习椅:Ming Zeng, MD PhD、Sichuan Academy of Medical Science
- 学习椅:Hongwei Zhang, MD PhD、Xijing Hosptial, GI institute
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
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.
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