JPRN-jRCTs041190072进行中（未招募）2 期
Quadruplet 1st line Treatment of CAPOXIRI plus Bevacizumab versus FOLFOXIRI plus Bevacizumab for mCRC, Multicenter Randomised Phase II study - QUATTRO-II
Tsuji Akihito0 个研究点目标入组 112 人开始时间: 2019年10月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Obtaining informed consent prior to study-specific screening procedures
- •2.Histologically-confirmed colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer
- •3.Clinically-confirmed metastatic colorectal cancer
- •4.Age>=20 years at the time of informed consent
- •5.ECOG performance status (PS) of 0,1
- •6.Patients who has one or more lesion(s) of diameter 1 cm or larger (RECEST v1.1) be able to assess continuously on the basis of the protocol by contrast enhanced CT.
- •7.Untreated metastatic colorectal cancer. Patients who underwent to adjuvant chemotherapy can be enrolled after 24 weeks from last administration.
- •8.RAS / BRAF testing was performed and confirmed RAS / BRAF wild type or mutation type
- •9.Adequate organ function according to following laboratory values obtained within 14 days before enrolment (excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test)
- •i. Neutrophil count: >= 1200/mm3
- •ii. Platelet count: >= 10.0 x 104/mm3
- •iii. Hemoglobin: >= 9.0 g/dL
- •iv. Total bilirubin: =< 1.5 x ULM
- •v. AST, ALT, ALP: =< 2.5 x ULM (<5 x ULM if liver metastases present)
- •vi. Serum creatinine: =<1.5 x ULM or Ccr >30 ml/min
- •vii. Protein Urea: =< 2+ (In case of >= 3+, UPC (Urine protein / creatinine ratio: < 2.0)
- •10.Confirmed UGT1A1 wild type or UGT1A1 single hetero type
排除标准
- •1.Previously treated with irradiation to bone marrow constituting 20% or more of irradiation field.
- •2.Untreated brain metastases or spinal cord compression or primary brain tumors.
- •3.History of CNS disease.(except for asymptomatic lacunar stroke)
- •4.Requiring chronic systemic corticosteroid treatment.
- •5.Patients who have uncontrolled anticoagulant therapy.
- •6.History / Presence of thrombosis within 1 year requiring medication.
- •7.Previously participated in any clinical trials and treatment with any investigational drug within 28 days.
- •8.Patient with i) Uncontrolled hypertension, ii) Uncontrolled diabetes, iii) Uncontrolled diarrhea, iv) >grade 1 peripheral neuropathy, v) Active peptic ulcer, vi) Non-healing wound (except for central venous port), vii) Clinically significant cardiovascular disease (for example cerebrovascular accidents, myocardial infarction, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication), viii) Uncontrolled venous thromboembolism, xi) Evidence or requiring systemic treatment for Infectious disease, x) Clinically important diseases.
- •9.Major surgical procedure within 28 days prior to study treatment start, open biopsy, or significant traumatic injury, or anticipation of the need for major surgical procedure. (except for central venous port)
- •10.Lack of physical integrity of the upper gastrointestinal tract.
- •11.Pregnant women, lactating woman, positive by pregnancy test, wishing to become pregnant, and Sexually active males.
- •12.Hepatitis B or hepatitis C or Evidence of HIV infection.
- •13.History / Presence of paralytic ileus, obstruction or gastrointestinal perforation.
- •14.Other active co-existing malignancies.
- •15.History / Presence of paralytic ileus, obstruction or gastrointestinal perforation.
- •16.With massive pleural effusion or ascites
- •17.History of allergy to the drug of fluorouracil, oxaliplatin, irinotecan, bevacizumab and Chinese hamster ovary cell proteins of any components of the study medications.
- •18.History of fluoropyrimidine severe side effects caused by DPD defect.
- •19.Patients who underwent colonic stent.
- •20.Patient who is judged by the investigator to be inappropriate for study participation for any reason.
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