EUCTR2018-003346-17-SE进行中（未招募）1 期
Phase III Randomized clinical trial for stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy:OVHIPEC-2 - OVHIPEC2
KI-AV0 个研究点目标入组 535 人开始时间: 2021年7月7日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 535
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
- Female
入选标准
- •1. signed and written informed consent
- •2. age =18
- •3. histological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer, treated with primary complete cytoreduction, or primary cytoreduction with no more than 2.5 mm residual disease
- •a. in case of extra-abdominal enlarged lymph nodes, representative cytology/histology or FDG-PET scan must be negative;
- •b. resectable, local bowel involvement, iatrogenic abdominal wall metastases or umbilical lesions are allowed;
- •c. in case no histological proof is available before surgery, patients can be randomized during surgery based on
- •histological proof on intraoperative frozen section material
- •4. fit for major surgery, WHO performance status 0-2
- •5. adequate bone marrow function (hemoglobin level >5.5 mmol/L; leukocytes >3 x 109/L; platelets >100 x 109 /L)
- •6. adequate hepatic function (ALT, AST and bilirubin <2.5 times upper limit of normal)
- •a. in case of Gilbert’s disease: unconjugated bilirubin <5 times upper limit of normal
- •7. adequate renal function (creatinine clearance = 60 ml/min or ml/min/1,73 m2 using either MDRD, Cockcroft-Gault formula, or CKD-EPI)
- •8. baseline health-outcome questionnaire should be completed before randomization
- •9. able to understand the patient information and questionnaires.
- •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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. history of previous malignancy treated with chemotherapy
- •2. history of previous malignancy within five years prior to inclusion, with the exception of carcinoma in situ, radically excised basal cell or squamous cell cancer of the skin or synchronal endometrial carcinoma FIGO IA G1/2
- •3. if complete primary cytoreduction is not feasible, for the following reasons:
- •a. diffuse deep infiltration of the root of small bowel mesentery, or;
- •b. diffuse carcinomatosis of the small bowel that requires resection that leads to short bowel syndrome (remaining bowel <1.5 meter), or;
- •c. diffuse involvement/deep infiltration of stomach/duodenum, or;
- •d. diffuse involvement/deep infiltration of head or middle part of pancreas, or;
- •e. involvement of truncus coeliacus , hepatic arteries or left gastric artery, or;
- •f. non-resectable enlarged (larger than 10 mm short axis) lymph nodes
- •4. in case of a known psychiatric disorder, substance abuse disorder, or high suspicion of a mental disorder that could interfere with cooperation or compliance with the requirements of the trial
- •5. when opting for fertility sparing surgery, or when breastfeeding
- •6. in case of a known history of Human Immunodeficiency Virus (HIV, or HIV 1/2 antibodies)
- •7. in case of known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative])
- •8. patients who received prior treatment for the current malignancy.
研究者
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