EUCTR2019-001437-14-IT进行中（未招募）1 期
Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC CO2) versus standard surgery in colorectal carcinoma at high risk of peritoneal carcinomatosis. Short and long-term outcomes. A collaborative randomized controlled trial of: ACOI, FONDAZIONE AIOM, SIC, SICE, SICO. CHECK STUDY - CHECK STUDY
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with colon or rectosigmoid junction cancer eligible for R0 with:
- •1.Histologically documented colorectal adenocarcinoma:
- •a. Presurgical or intraoperative stage T4a or T4b Primary tumour (TNM 8 th)
- •b. Urgent presentation: perforation without purulent generalized peritonitis or fecal peritonitis
- •c. Peritumoral minimal peritoneal carcinomatosis: limited peritoneal disease in close proximity to the primary tumour, that may be removed en bloc
- •d. Ovarian metastases (Krukenberg tumor)
- •2.Age =18 and =75 years
- •3.Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 165
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 165
排除标准
- •1.Distant metastatic disease (even if limited and completely resected)
- •2.History of tumour diagnosed in the 3 years before entering the study, except for topical and healed pathologies that do not need further treatment (e.g. non-melanoma skin carcinomas, superficial bladder carcinomas or in situ carcinoma of the breast or cervix).
- •3.Psychological, family or social conditions which may negatively affect the treatment and follow-up protocol.
- •4.Poor general conditions (ECOG > 2).
- •5.Impaired cardiac function (history of congestive heart failure or FE <40%). Clinically significant cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrolment), myocardial infarction (<6 months prior to enrolment), unstable angina, congestive heart failure (New York Heart Association Classification Class > II or serious uncontrolled cardiac arythmia requiring medication
- •6.Impaired renal function (creatinine> 1.5 upper limit of normal or creatinine clearance <60 mL / min)
- •7.Impaired hepatic function (AST, ALT >2.5 upper limit of normal, bilirubin> 1.5 upper limit of normal)
- •8.Impaired hematopoietic function (leucocytes <4000 / mm3, neutrophils <1500 / mm3, platelets <100000 / mm3)
- •9.Impaired pulmonary function (presence of COPD or other pulmonary restrictive conditions with FEV1 <50% or DLCO <40% of normal age value).
- •10.Pregnancy
- •11.History or presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of HIPEC or chemotherapy or patient at high risk from treatment complications.
- •12.Chronic inflammatory bowel disease
- •13.Patients with acute bowel obstruction
- •14.Refusal to join the study
研究者
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