EUCTR2014-002665-30-DE进行中（未招募）1 期
Effect of chemotherapy alone vs. chemotherapy followed by surgical resection on survival and quality of life in patients with limited-metastatic adenocarcinoma of the stomach or esophagogastric junction – a phase III trial of AIO/CAO-V/CAOGI - Renaissance / FLOT5
Krankenhaus Nordwest gGmbH0 个研究点目标入组 271 人开始时间: 2015年10月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 271
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.Histologically confirmed limited metastatic gastric or GEJ adenocarcinoma.*
- •2.Medical and technical operability of the primary.
- •3.Metastatic lesions are resectable or can be controlled by local ablative procedure (central evaluation).
- •4.No prior chemotherapy and no prior tumor resection.
- •5.Female and male patients >18 years. Patients in reproductive age must be willing to use adequate contraception during the study and 3 months after the end of the study (Appropriate contraception is defined as surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)). Female patients with childbearing potential need to have a negative pregnancy test within 7 days before study start.
- •6.ECOG 0 or 1
- •7.Adequate hematological, hepatic and renal function parameters:
- •-Leukocytes = 3000/µl
- •-Platelets = 100,000/µl
- •-Serum creatinine = 1.5 x upper limit of normal, or GFR > 40 ml/min
- •-Bilirubin = 1.5 x upper limit of normal
- •-AST and ALT = 3.5 x upper limit of normal
- •-Alkaline phosphatase = 6 x upper limit of normal
- •8.Written informed consent of the patient.
- •(*) Definition of the limited metastatic status according Flot3-study with modification is:
- •1.Retroperitoneal lymph node metastases (RPLM) (e.g., para-aortal, intra-aorto-caval, parapancreatic or mesenterial lymph nodes) only
- •2.at maximum one organ involved with or without RPLM according to the following schema:
- •I.Localized potentially operable peritoneal carcinomatosis: stage P1 according to classification of the „Japanese Research Society for Gastric Cancer (Clinically visible carcinomatosis of the peritoneum or of the pleura and >P1 peritoneal carcinomatosis are not allowed!) or
- •II.Liver: maximum of 5 metastatic lesions that are potentially resectable or
- •III.Lung: unilateral involvement, potentially resectable or
- •IV.Uni- or bilateral Krukenberg tumors (ovarian met.) in the absence of macroscopic peritoneal carcinomatosis or
- •V.Uni- or bilateral adrenal gland metastases or
- •VI.Extra-abdominal lymph node metastases such as supraclavicular lymph node involvement or
- •VII.Localized bone involvement (defined as being within one radiation field) or
- •VIII.Other metastatic disease location that is considered limited by the investigator and is confirmed by the review committee
- •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 271
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 271
排除标准
- •1.Medical inoperability
- •2.Inability to understand the aims of the study and/or protocol procedures
- •3.Metastatic disease not fulfilling the criteria of limited disease mentioned in the inclusion criteria or non-metastatic stage (cM0)
- •4.Cirrhosis of the liver, pronounced alcohol abuse with anticipated detoxification, severe pulmonary infection with considerable reduction of pulmonary function
- •5.Primary not resectable
- •6. Hypersensitivity to 5-fluorouracil, leucovorin, oxaliplatin, or docetaxel
- •7. Contraindication versus 5-fluorouracil, leucovorin, oxaliplatin, or docetaxel (see specific product information)
- •8.Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV
- •9.Clinically significant valvular defect
- •10.Past or current history of other malignancies unless curatively treated and without evidence of disease for more than 3 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix
- •11.Known brain metastases
- •12.Other severe internal disease or acute infection
- •13.Peripheral polyneuropathy > NCI grade II
- •14.Serious hepatic impairment (AST/ALT>3.5xULN, AP>6xULN, bilirubin>1.5xULN)
- •15.Chronic inflammatory bowel disease
- •16.Any other concurrent antineoplastic treatment including irradiation
- •17.Participation in another clinical study
- •18.Pregnancy or lactation
研究者
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