EUCTR2014-004436-19-IT进行中（未招募）不适用
First-line FOLFOXIRI plus bevacizumab followed by reintroduction of FOLFOXIRI plus bevacizumab at progression versus FOLFOX plus bevacizumab followed by FOLFIRI plus bevacizumab at progression in first- and second line treatment of unresectable metastatic colorectal cancer patients - Tribe-2
G.O.N.O.0 个研究点开始时间: 2014年11月11日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Histologically proven diagnosis of colorectal cancer
- •-Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease
- •-At least one measurable lesion according to RECIST1.1 criteria
- •-Availability of a tumoral sample
- •-Male or female of 18-75 years of age
- •-ECOG PS < or = 2 if aged < 71 years, ECOG PS = 0 if aged 71-75 years
- •-Life expectancy of at least 12 weeks
- •-Previous adjuvant chemotherapy allowed only if with fluoropyrimidine monotherapy and more than 6 months elapsed between the end of adjuvant and first relapse
- •-Neutrophils >1.5 x 109/L, Platelets >100 x 109/L, Hgb >9 g/dl
- •-Total bilirubin 1.5 time the upper-normal limits (UNL) of the normal values and ASAT (SGOT) and/or ALAT (SGPT) <2.5 x UNL (or <5 x UNL in case of liver metastases) alkaline phosphatase <2.5 x UNL (or <5 x UNL in case of liver metastases)
- •-Creatinine clearance >50 mL/min or serum creatinine 1.5 x UNL
- •-Urine dipstick of proteinuria <2+. Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate <1 g of protein/24 hr
- •-Women of childbearing potential must have a negative blood pregnancy test at the baseline visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive.
- •-Subjects and their partners must be willing to avoid pregnancy during the trial and until 6 months after the last trial treatment. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore,
- •be willing to use adequate contraception as approved by the investigator (barriere contraceptive measure or oral contraception)
- •-Will and ability to comply with the protocol
- •-Written informed consent to study procedures and to molecular analyses.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 354
排除标准
- •Radiotherapy to any site within 4 weeks before the study
- •-Previous adjuvant oxaliplatin-containing chemotherapy
- •-Previous treatment with bevacizumab
- •-Untreated brain metastases or spinal cord compression or primary brain tumours
- •-History or evidence upon physical examination of CNS disease unless adequately treated
- •-Symptomatic peripheral neuropathy > 2 grade NCIC-CTG criteria
- •-Serious, non-healing wound, ulcer, or bone fracture
- •-Evidence of bleeding diathesis or coagulopathy
- •-Uncontrolled hypertension and prior histor of hypertensive crisis or hypertensive encephalopathy
- •-Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (=6 months), myocardial infarction (=6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
- •-Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months of study enrolment.
- •-Any previous venous thromboembolism > NCI CTCAE Grade 3.
- •-History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment.
- •-Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes
- •Chronic, daily treatment with high-dose aspirin (>325 mg/day)
- •-Treatment with any investigational drug within 30 days prior to enrollment or 2 investigational agent half-lives (whichever is longer)
- •-Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ
- •-Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study
- •-Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication
- •-Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barriere contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment.
研究者
相似试验
已完成
2 期
Phase II trial of FOLFOXIRI + Bevacizumab in patients with untreated metastatic colorectal cancerPatients with metastatic colorectal cancerJPRN-UMIN000017102Translational Research Informatics Center, Foundation for Biomedical Research and Innovation45
进行中（未招募）
不适用
Phase II trial FOLFOX combined with Bevacizumab, Cetuximab and Imatinib in patients with advanced untreated colorectal cancer - NDEUCTR2006-001779-39-ITAzienda Ospedaliera Universitaria S.Martino - U.O. Oncologia Medica - Genova
招募中
2 期
A phase II trial of FOLFOXIRI+Bevacizumab as preoperative chemotherapy for locally advanced lower rectal cancerower rectal cancerJPRN-UMIN000031028Kobe University Graduate School of Medicine40
进行中（未招募）
不适用
patients with colorectal carcinoma compared to patients with normal LDH serum levelspatients treated with first-line chemotherapy and bevacizumab will be prospectively stratified according to LDH serum levelsEUCTR2012-005048-46-ITFondazione GISCAD
已完成
不适用
Efficacy and Safety of FOLFOXIRI plus Bevacizumab and Doublet plus Biologics in Patients With Previously Untreated BRAF V600E-mutant Metastatic Colorectal Cancer: A Multi-institutional retrospective study (WJOG13219G)BRAF V600E-mutant Metastatic Colorectal CancerJPRN-UMIN000041098West Japan Oncology Group250