An open randomized controlled clinical trial to evaluate the efficacy of a maintenance therapy with supplements containing I3C and EGCG in ovarian cancer patients

Russian Scientific Center of Roentgenoradiology0 个研究点目标入组 284 人开始时间: 2016年3月24日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1) diagnosis of histologically confirmed International Federation Gynecology Obstetrics (FIGO) stage III serous ovarian cancer
•2) patients with a general condition corresponding to WHO 0-2
•3) absolute granulocyte count >= 1.5 x 10^3/mm^3; platelets >= 100 x 10^3/mm^3
•4) adequate liver and renal function (bilirubin, creatinine within normal limits; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.0 times upper normal limit;
•AST and ALT must be < 5.0 times upper normal limit if liver metastases present)
•5) absence of significant coexisting diseases (documented history of gastric/duodenal ulcer within last 12 months, polyneuropathy, decompensated diabetes, heart attack within 1 year ago)
•6) written informed consent

•1) point mutations in the BRCA genes
•2) malignant tumors of other localizations
•3) positive RW or HIV tests, alcohol or drug abuse
•4) pregnancy or lactation
•5) organizational problems which could impair the ability to commit treatment and monitoring (remote accommodation etc.)
•6) psychiatric illness or uncontrolled psychiatric condition which may hamper compliance with the trial protocol
•7) severe coexisting disease which may, in the opinion of the investigator influence the patient's ability to participate in the study

发起方

Russian Scientific Center of Roentgenoradiology