CTRI/2017/09/009607招募中2 期
CYTOREDUCTIVE SURGERY WITH HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY (HIPEC) FOR RECURRENT CARCINOMA OF OVARY - HIPEC-ovary
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
- •A. Patients affected by a peritoneal recurrence of ovarian cancer.
- •B. DISEASE AMENABLE TO COMPLETE CYTOREDUCTIVE SURGERY AS INDICATED BY:
- •Ovarian cancer limited to the abdominal cavity with or without extra-peritoneal spread considered resectable at preoperative and intra-operative evaluation.
- •No clinical, biochemical or radiological signs of biliary obstruction, ascites.
- •Small volume of disease in the gastro-hepatic ligament defined as mass less than 5 cm in the epigastric region on cross-sectional imaging.
- •No cross-sectional imaging findings indicative of multi-segmental (More than- 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 vascularity.
- •Absence of unresectable deposits over the small intestinal serosa/ mesentery or more than 1/3 rd of small bowel involvement,
- •No clinical or radiological evidence of distant disease excluding the supraclavicular, inguinal metastases and pleural effusion.
- •C. PATIENT CHARACTERISTICS:
- •Age over 18 and under 70 years
- •ECOG-performance status <= 2
- •Absolute neutrophil count > 1,500/mm³
- •WBC > 4,000/mm³ and Platelet count 150,000/mm³
- •INR <= 1.5 Patients on therapeutic anticoagulant for unrelated medical condition such as atrial fibrillation or anti-thrombocyte treatment allowed provided treatment can be withheld for operation
- •Total serum bilirubin <= 1.5 mg/dL
- •Alkaline phosphatase < 2.5 times upper limit of normal (ULN)
- •SGOT < 1.5 times ULN
- •Serum creatinine and Blood Urea Nitrogen are normal
- •No history of severe congestive heart failure or severe pulmonary diseases.
- •Patients 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
排除标准
- •Patients who have platinum resistant recurrence ( < 6 months of protocol first line treatment )
- •Non-epithelial ovarian cancer or borderline ovarian tumor
- •Patients affected by major depressive disorder even in treatment or minor mood disorders
- •Patients with severe impairment of respiratory, hepatic or renal function
- •Patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease
- •Patients with active infection or other neoplastic disease in progress
- •Patients with bowel obstruction
- •Inadequate bone marrow function
- •No clear-peritoneal disease at surgical exploration
- •Patients on maintenance therapy with Antiangiogenic drugs
研究者
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