CTRI/2017/08/009498招募中2 期
Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) in peritoneal carcinomatosis from colorectal cancer - HIPEC- Colon
Investigator initiated trial0 个研究点目标入组 15 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Disease characteristics:
- •A.Histologically confirmed adenocarcinoma of the colon or rectum meeting the following criteria:
- •I.Synchronous or metachronous limited peritoneal disease dissemination, as described below
- •II.No appendiceal cancer
- •III.No signet ring cell type
- •B.Disease amenable to complete cytoreduction surgery as indicated by:
- •I.Peritoneal Cancer Index (PCI) <= 20 by helical CT scan and/or staging laparoscopy
- •II.Up to 3 small, resectable parenchymal hepatic metastases
- •III.No clinical, biochemical or radiological signs of biliary obstruction
- •IV.No symptomatic malignant ascites requiring palliative paracentesis
- •V.Small volume of disease in the gastro-hepatic ligament defined by a < 5 cm mass in the epigastric region on cross-sectional imaging
- •VI.No cross-sectional imaging findings indicative of multi-segmental ( > 1 site) small bowel obstruction, small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening, or loss of mesenteric vascular clarity
- •VII.Absence of unresectable deposits over the small intestinal serosa/ mesentery
- •VIII.No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal, or para-aortic) metastasis
- •C.Prior/Concurrent Therapy:
- •Patients who received prior adjuvant therapy for colorectal adenocarcinoma and/or prior first-line systemic therapy for metastatic colorectal adenocarcinoma are eligible for inclusion in the study.
- •Patient characteristics:
- •1.ECOG performance status 0-1
- •2.Age <65 years
- •3.Absolute neutrophil count > 1,200/mm³
- •4.WBC > 4,000/mm³
- •5.Platelet count 150,000/mm³
- •6.INR <= 1.5
- •7.Patients on therapeutic anticoagulant for unrelated medical condition such as atrial fibrillation or anti-thrombocyte treatment allowed provided treatment can be withheld for operation
- •8.Total serum bilirubin <= 1.5 mg/dL
- •9.Alkaline phosphatase < 2.5 times upper limit of normal (ULN)
- •10.SGOT < 1.5 times ULN
- •11.Serum creatinine normal
- •12.BUN normal
排除标准
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No history of severe congestive heart failure or severe pulmonary disease
- •oPatients who are status post-revascularization procedures with satisfactory cardiac function are eligible
- •No acute myocardial infarction within the past 6 months
- •No significant history of a medical problem or co-morbidity (e.g., severe congestive heart failure or active ischemic heart disease) that would preclude a major abdominal operation
- •No concurrent second malignancy requiring systemic therapy
- •No psychiatric or addictive disorders, or other conditions that would preclude the patient from meeting the study requirements
研究者
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