PER-160-08
已完成
未知
A Randomized Phase-II Study of Patients With Locally Advanced Gastric of Gastro-Esophageal Adenocarcinoma Treated With Induction Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Adjuvant Intraperitoneal Floxuridine, Followed by Prolonged Administration of Capecitabine
ew York University School of Medicina,0 个研究点目标入组 0 人2009年3月30日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- -C16 Malignant neoplasm of stomach
- 发起方
- ew York University School of Medicina,
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Only untreated patients with histologically documented gastric/GEJ adenocarcinoma, clinical American Joint Committee on Cancer (AJCC) stage grouping (11\) IB\-IV (Mo) by CT scan and laparoscopy/endoscopic ultrasound, are eligible. Excluded are patients in need of urgent surgery for gastro\-intestinal obstruction, perforation or hemorrhage.
- •Both men and women \>\= 18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status 0\-2, members of any ethnic group and minorities.
- •Since immune deficiency increases the risk of terminal infections when aggravated by bone marrow suppressive therapy, patients must be without active or uncontrolled infection including HIV.
- •Patients without psychiatric disorders that may interfere with their consent and/or with protocol follow\-up.
- •An adequate bone\-marrow reserve (absolute neutrophil count \>\= 1,500/ mmL, thrombocytes \>\= 100,000 mmL, hemoglobin \>\= 9 gm/dL).
- •Preserved liver and renal function (total serum bilirubin \<2 mg/dL, SGOT/SGPT \=\< 3x the upper limit of normal, alkaline phosphatase \=\< 3x the upper limit of normal, blood urea nitrogen (BUN) \=\< 30 mg/dL, serum creatinine concentration \<1\.5 mg/dL and creatinine clearance \>\= 50 mL/min) are required. Creatinine clearance should be normalized for 1\.73 M^2 BSA. The prothrombin time, activated partial thromboplastin time, and thrombin time should be within the range of normal values.
- •Since chemotherapeutic agents to be used are known or suspected to be teratogenic or with other adverse effects, women must not be pregnant or breast\-feeding. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. All patients of reproductive age may not participate unless they agree to use an effective medically acceptable contraceptive method.
- •Patients who signed written informed consent.
排除标准
- •Patients with another invasive malignancy, with adequately treated basal cell or squamous cell skin cancer, free for 5 years or more of in\-situ cervix cancer or other in\-situ cancer.
- •Patients with diagnosed Gilbert´s disease and bilirubin level \>\= 2\.0 mg/dL, as these patients may have excessive CPT\-11 toxicity.
- •Prior severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5\-fluorouracil. Capecitabine (Xeloda) is contraindicated in patients with severe renal impairment, i.e., creatinine clearance below 30 mL/min, determined by Cockcroft\-Gault equation shown on page 15 under (i) Renal impairment. In patients with moderate renal impairment (creatinine clearance 30\-50 mL/min), which develops during the course of adjuvant treatment with Capecitabine, the drug is decreased to 75% of the starting dose.
- •Any severe concurrent disease, such as cardiac condition not responding to medication, myocardial infarction within the last 12 months, active infection or uncontrolled pulmonary disease, or any other disease which in judgment of the investigator would make the patient inappropriate for entry into this study.
结局指标
主要结局
未指定
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