Combination Chemotherapy and Surgery in Treating Patients With Locally Advanced Stomach Cancer
A Phase III Trial of Preoperative vs. Postoperative Chemotherapy With Taxotere-Cisplatin-5FU (TCF) in Patients With Locally Advanced Operable Gastric Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with surgery may kill more tumor cells. It is not yet known if chemotherapy followed by surgery is more effective than surgery followed by chemotherapy for stomach cancer.
PURPOSE: This randomized phase III trial is studying surgery followed by combination chemotherapy to see how well it works compared to combination chemotherapy followed by surgery in treating patients with locally advanced stomach cancer.
研究概览
详细说明
OBJECTIVES:
- Compare, by intention to treat analysis, feasibility and efficacy of 4 courses of docetaxel, cisplatin, and fluorouracil as preoperative or postoperative chemotherapy in patients with locally advanced operable gastric carcinoma.
- Evaluate the predictive values of some biological and molecular tumor parameters on response to chemotherapy, metastasis and survival in this patient population.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to study center, tumor site (affecting the Z-line (cardia carcinoma Siewart II and III) vs rest of the stomach), and nodal status (positive vs negative). Patients are randomized to either preoperative chemotherapy followed by surgery (arm I) or surgery followed by postoperative chemotherapy (arm II).
- Arm I: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 4 hours on day 1, and fluorouracil IV continuously on days 1-14 every 3 weeks. Patients are evaluated after 2 courses and patients with progressive disease proceed to immediate surgery. Otherwise, treatment continues for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Between 3-5 weeks following day 1 of the last course of chemotherapy, patients undergo gastric resection.
- Arm II: Patients undergo immediate gastric resection. Beginning 3-6 weeks after surgery, patients receive 4 courses of docetaxel, cisplatin, and fluorouracil as in arm I.
Quality of life is assessed before the first and third courses of chemotherapy, before and after surgery, and then at 1, 3, and 6 months.
Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 240 patients (120 per arm) will be accrued for this study.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
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
DISEASE CHARACTERISTICS:
Histologically confirmed locally advanced gastric carcinoma that is considered operable
- T3-4, Nx, M0 OR
- Tx, N+, M0
Lymph nodes considered positive by sonography should be at least 2 of the following:
- Round
- Echopoor
- Sharp borders
- At least 0.5 cm
No distant metastases, including peritoneal carcinomatosis
- CT scan and peritoneal lavage mandatory
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- 0-2
Life expectancy:
- Greater than 12 weeks
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin normal
- AST or ALT no greater than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Adequate renal function within limits to allow for treatment with cisplatin
Cardiovascular:
- No unstable cardiac disease requiring treatment
- No congestive heart failure or angina pectoris even if medically controlled
- No significant arrhythmias
- No myocardial infarction within past 6 months
- Ejection fraction greater than 50% on cardiac sonography or MUGA scan
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy except basal cell carcinoma of the skin or adequately treated carcinoma in situ of the cervix
- No grade 2 or greater peripheral neuropathy of any origin (e.g., alcohol, diabetic)
- No history of anaphylaxis
- No other serious concurrent illness or medical condition that would preclude study therapy
- No history of significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biologic therapy for gastric carcinoma
Chemotherapy:
- No other concurrent chemotherapy for gastric carcinoma
Endocrine therapy:
- No concurrent endocrine therapy for gastric carcinoma
Radiotherapy:
- No concurrent radiotherapy for gastric carcinoma
Surgery:
- See Disease Characteristics
Other:
- At least 30 days since prior treatment in a clinical trial
- No other concurrent experimental drugs
- No other concurrent anticancer therapy
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：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Taxotere-Cisplatin-5FU preoperatively
TCF preoperatively
|
Preoperatively
|
|
有源比较器：Immediate surgery followed by TCF
Surgery followed by Taxotere-Cisplatin-5FU
|
Immediate surgery followed by Taxotere-Cisplatin-5FU
|
研究衡量的是什么？
主要结果指标
结果测量 |
|---|
|
无事件生存
|
次要结果测量
结果测量 |
|---|
|
总生存期
|
|
完成研究治疗后测量的治疗失败时间
|
|
Toxicity measured after completion of study treatment
|
|
Rate of complete resection (RO) and postoperative mortality as measured after surgery
|
合作者和调查者
调查人员
- 学习椅：Rudolf Morant, MD、Tumor Zentrum ZeTup St. Gallen und Chur
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 (估计)
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.
Taxotere-Cisplatin-5FU的临床试验
-
Mast Therapeutics, Inc.University of California, San Diego完全的
-
Japan Clinical Oncology GroupMinistry of Health, Labour and Welfare, Japan终止
-
Galenic Research Institute Ltd完全的
-
Groupe Oncologie Radiotherapie Tete et CouGustave Roussy, Cancer Campus, Grand Paris完全的
-
Andrew Hendifar, MDJanssen Research & Development, LLC; Ipsen完全的