EUCTR2006-006072-38-SE进行中（未招募）不适用
A Randomised Two Arm Phase III Study in Patients Post Radical Resection of Liver Metastasis of Colorectal Cancer to Investigate Bevacizumab (q3w) in Combination With Capecitabine Plus Elaoxantin (XELOX) (q3w) as Adjuvant Chemotherapy vs XELOX (q3w) alone as Adjuvant Treatment - Hepatica
the Dutch Colorectal Cancer Group0 个研究点目标入组 620 人开始时间: 2007年9月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 620
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.Signed written informed consent obtained prior to any study-specific procedure.
- •2.Age = 18 years.
- •3.Liver metastases radically resected (R0 resection)
- •4.Study medication started =4 and = 8 weeks post liver surgery.
- •5.Histologically confirmed liver metastasis of colorectal cancer after surgery.
- •6.ECOG performance status 0 or 1 (Appendix 1).
- •7.Adequate hematology: neutrophils =1.5 x 109/L, platelets =100 x 109/L, Hb =5.5 mmol/L, INR = 1.5, APTT < 1.5 X UNL.
- •8.Adequate biochemistry: total bilirubin =1.5 UNL, ASAT and ALAT =2.5 x UNL, alkaline phosphatase =2.5 x UNL, serum creatinin =1.5 UNL.
- •9.Urine dipstick <2+ for protein.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1Extrahepatic metastatic disease.
- •2Adjuvant chemotherapy given <6 months prior to detection of the liver metastases.
- •3Chemotherapy for metastatic disease.
- •4Prior non colorectal malignancies, except adequately treated basalioma of the skin or carcinoma in situ of the cervix.
- •5Bleeding diathesis or coagulation disorders or the need for full-dose anticoagulation.
- •6Major surgical procedure <4 weeks prior to start of study treatment.
- •7Females with a positive pregnancy test (within 14 days before treatment start).
- •8Lactating women.
- •9Fertile women (<2 years after last menstruation) and women of childbearing potential not willing to use effective means of contraception.
- •10History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake.
- •11Clinically significant (i.e. active) cardiovascular disease e.g. cerebrovascular accidents (=6 months prior to randomisation), myocardial infarction (=1 year prior to randomisation), uncontrolled hypertension while receiving chronic medication, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhytmia requiring medication.
- •12Lack of physical integrity of the upper gastro-intestinal tract, malabsorption syndrome, or inability to take oral medication.
- •13Known peripheral neuropathy, including oxaliplatin-induced neuropathy > grade 1. Absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible.
- •14Organ allografts requiring immunosuppressive therapy.
- •15Serious, non-healing wound, ulcer, or bone fracture.
- •16Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes.
- •17Chronic, daily treatment with high-dose asprin (>325 mg/day) or nonsteroidal anti-inflammatory medications (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases). Patients can be rendered eligible by changing the treatment to COX II inhibitors.
- •18Chronic treatment with corticosteroids (dose of =10 mg/day methylprednisolone equivalent excluding inhaled steroids).
- •19Serious intercurrent infections (uncontrolled or requiring treatment).
- •20Current or recent (within the 28 days prior to randomisation) treatment with another investigational drug or participation in another investigational study.
- •21Patients with known allergy to Chinese hamster Ovary cell proteins or other recombinant human or humanized antibodies or to any excipients of bevacizumab formulation, platinum compounds or to any other component of the study drugs.
研究者
相似试验
进行中（未招募）
1 期
Effects of a medication being studied (rilematovir) in infants and children and subsequently neonates in the hospital with a respiratory infection due to RSVRespiratory Syncytial VirusMedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2020-002023-11-HUJanssen-Cilag International NV737
进行中（未招募）
1 期
Efficacy and safety of adding LX4211 (an investigational oral compound) for patients with Type 1 Diabetes Mellitus (T1D) who have inadequate control of their blood glucose (sugar) levels on insulin alone.Type 1 Diabetes MellitusEUCTR2014-005153-39-LTexicon Pharmaceuticals, Inc.750
进行中（未招募）
1 期
Effects of a medication being studied (rilematovir) in infants and children and subsequently neonates in the hospital with a respiratory infection due to RSVEUCTR2020-002023-11-SEJanssen-Cilag International NV737
进行中（未招募）
1 期
A Study of the Effects of AMG 334 to Prevent Migraine HeadachesEUCTR2014-004464-38-NLAmgen Inc852
进行中（未招募）
1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)Immunoglobulin A Nephropathy (IgAN)EUCTR2020-003084-26-CZChinook Therapeutics U.S., Inc.320