EUCTR2019-001478-27-IT进行中（未招募）1 期
Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC CO2) versus standard surgery in gastric carcinoma at high risk of peritoneal carcinomatosis. Short and long-term outcomes. A collaborative randomized controlled trial of: ACOI, FONDAZIONE AIOM, SIC, SICE, SICO. GOETH STUDY - GOETH STUDY
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •1.Patients with histologically documented gastric carcinoma (diffuse/intestinal histotype) eligibile for R0:
- •a)Presurgical or intraoperative stage T3-T4 N0-N+ primary tumour (TNM 8 th).
- •b)Urgent presentation: perforation without purulent generalized peritonitis
- •c)Positive cytology of peritoneal fluid (if previously obtained)
- •2.Age = 18 years 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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1.Gastroesophageal Junction (GEJ) cancer
- •2.Distant metastatic disease (even if limited and completely resected)
- •3.Peritoneal carcinomatosis
- •4.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).
- •5.Psychological, family or social conditions which may negatively affect the treatment and follow-up protocol.
- •6.Poor general conditions (ECOG > 2).
- •7.Impaired cardiac function (history of congestive heart failure or FE <40%). Clinically significant cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrolment), unstable angina, congestive heart failure (New York Heart Association Classification Class > II) or serious uncontrolled cardiac Arrhythmia requiring medication
- •8.Impaired renal function (creatinine> 1.5 upper limit of normal or creatinine clearance <60 mL / min).
- •9.Impaired hepatic function (AST, ALT >2.5 upper limit of normal, bilirubin > 1.5 upper limit of normal).
- •10.Impaired hematopoietic function (leucocytes <4000 / mm3, neutrophils <1500 / mm 3, platelets <100000 / mm3).
- •11.Impaired pulmonary function (presence of COPD or other pulmonary restrictive conditions with FEV1 <50% or DLCO <40% of normal age value).
- •12.History or presence of other disease, 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.
- •13.Pregnancy.
- •14.Krukenberg tumor
- •15.Refusal to join the study.
研究者
相似试验
进行中（未招募）
1 期
Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy versus standard surgery in colorectal carcinoma at high risk of peritoneal carcinomatosispatients with colorectal carcinoma at high risk peritoneal carcinomatosisMedDRA version: 21.1Level: PTClassification code 10061045Term: Colon neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-001437-14-ITAssociazione Chirurghi Ospedalieri Italiani330
进行中（未招募）
不适用
Surgery plus intraperitoneal hyperthermic chemoterapy in platinum-resistant patients with ovarian cancer reccurrence. A Phase II study.EUCTR2005-000929-31-ITPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
进行中（未招募）
不适用
Surgery plus intraperitoneal Hypertermic chemotherapy in platinum-sensitive patients with ovarian cancer recurrence after 12 months. Phase II studyRecurrent ovarian cancerMedDRA version: 6.1Level: PTClassification code 10033128EUCTR2005-000927-41-ITPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
已完成
Unknown
Cytoreductive Surgery plus Hyperthermic Intraperitoneal Chemotherapy versus R0 Resection for Resectable Colorectal Cancer with Peritoneal Metastases with Low Peritoneal Cancer Index Score: A Collaborative Observational Study from Korea and JapaColorectal Cancer with Peritoneal MetastasesJPRN-UMIN000051539Yonsei University College of Medicine166
进行中（未招募）
1 期
Feasibility of a chemotherapy with the two agents Carboplatin and Paclitaxel, that is applied heated directly into the abdomen after surgery of patients with advanced cancer of the ovaryOtherwise treatment-naive patients with epithelial ovarian cancer, FIGO III - IVaEUCTR2012-003244-76-ATMedical University of Vienna20