EUCTR2010-022754-17-GB进行中（未招募）1 期
Bevacizumab And Combination Chemotherapy in rectal cancer Until Surgery: A Phase II, Multicentre, Open-label, Randomised Study of Neoadjuvant Chemotherapy and Bevacizumab in Patients with MRI defined High-Risk Cancer of the Rectum - BACCHUS
niversity College London0 个研究点目标入组 20 人开始时间: 2012年7月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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 confirmed diagnosis of adenocarcinoma of the rectum
- •Distal part of the tumour within 4–12 cm of the anal verge
- •No unequivocal evidence of established metastatic disease (on chest/abdominal/pelvis CT). Patients with equivocal lesions (as determined at MDT) are eligible
- •MRI-evaluated locally advanced tumour:
- •T3b, T3c or T3d and N0–N2
- •OR presence of macroscopic extramural venous invasion (V2 disease)
- •AND T3 tumour must be =2mm from the mesorectal
- •Measurable disease (using RECIST criteria, v1.1)
- •WHO performance status 0 or 1
- •In the opinion of the investigator:
- •General condition considered suitable for radical pelvic surgery
- •Candidate for systemic therapy with FOLFOX/FOLFOXIRI plus bevacizumab
- •Adequate bone marrow, hepatic and renal function:
- •Haemoglobin =8.0 g/dL
- •ANC =2 x 10^9/L
- •Platelet count =100 x 10^9/L
- •ALT or AST =1.5 x ULN (upper limit of normal)
- •ALP =1.5 x ULN
- •Total bilirubin =1.5 x ULN
- •Serum creatinine =1.5 x ULN
- •Creatinine clearance =50 mL/min using the Cockroft–Gault formula.
- •If the calculated GFR is below <50 ml/min, GFR should be assessed using
- •51Cr-EDTA or 99mTc-DTPA method to confirm GFR is =50 ml/min
- •INR = 1.1
- •Urine protein =1 with dipstick or urine analysis. For proteinuria >1+ or urine protein/creatinine ratio =1.0, 24-hour urine protein should be obtained and the level must be <2g for eligibility
- •No evidence of established or acute ischaemic heart disease on ECG and normal clinical cardiovascular assessment
- •No known significant impairment of intestinal absorption
- •At least 18 years of age, but not more than 70 years
- •Willing and able to give informed consent, comply with treatment and follow up schedule
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Primary tumour or lymph node on MRI extending =1mm from, or breaching the circumferential resection margin
- •Disease outside of the mesorectal envelope (internal iliac/ lateral pelvic lymph node)
- •Clinically significant cardiovascular or coronary disease (including myocardial infarction, angina (stable or unstable), symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) =2 years before randomisation
- •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
- •History of an arterial thromboembolic event during the previous 2 years. This includes myocardial infarction (MI), transient ischaemic attack (TIA), cerebrovascular accident (CVA), symptomatic peripheral vascular disease or other relevant history in the opinion of the investigator
- •Evidence of bleeding problems or coagulopathy
- •Significant and continuing rectal bleeding leading to a haemoglobin <8 g/dL
- •Patients receiving warfarin/coumarin derived anticoagulants at full therapeutic doses are excluded, but prophylactic doses of 1 mg to prevent Hickman line clotting are eligible
- •Chronic use of aspirin (>325 mg/day) or clopidrogel (>75 mg/day) within 10 days of first planned study treatment
- •Require regular use of anti-diarrhoeal (i.e. daily use of loperimide)
- •Serious uncontrolled intercurrent illness including poorly controlled diabetes mellitus
- •Known hypersensitivity to any of the study drugs
- •Serious wound, ulcer or bone fracture
- •Current or impending rectal obstruction
- •Metallic colonic or rectal stent in situ
- •patietns with ileostomy will not be able to participate IF they require
- •regular use of anti-diarrhoeal medication
- •Previous pelvic radiotherapy
- •Previous intolerance to fluoropyrimidine chemotherapy
- •Previous treatment with bisphosphonates
- •Infectious illness requiring antibiotics within 1 week of randomisation
- •Previous treatment with another investigational agent within 30 days prior to randomisation
- •Patients with a history of previous malignancy in the past 5 years, excepting basocellular or squamous cell skin cancer, or properly treated cervicouterine cancer in situ
- •Known HIV, HBV or HCV infection
- •Current smoker, or clinically relevant history of drug or alcohol abuse
- •Pregnant or lactating women or pre menopausal women not using adequate contraception. Men and women of child-bearing potential must use adequate contraception
- •Patients with any other condition or concurrent medical or psychiatric disease who, in the opinion of the investigator, is not eligible to enter the study
- •Inability or unwillingness to comply with the protocol
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