EUCTR2008-002902-20-SI进行中（未招募）不适用
Preoperative Radiotherapy with Capecitabine and Bevacizumab in locally advanced rectal cancer: CRAB Phase II study - CRAB
Onkološki inštitut Ljubljana0 个研究点开始时间: 2008年9月19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
入选标准
- •Male or female patients with histologically proven adenocarcinoma of the rectum (tumour located below the peritoneum), T3/4 or any node positive disease (clinical stage according the TNM classification system)
- •No evidence of metastatic disease.
- •The disease must be considered either resectable at the time of entry or thought to become resectable after preoperative chemoradiation.
- •Age 18 - 80 years
- •WHO Performance Status 0-2
- •No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer
- •Adequate hematological, hepatic and renal function as following:
- •-ANC =1.5 x 109/L and Platelets =100 x 109/L
- •-Total bilirubin =1.5 x the upper-normal limits (UNL) of the Institutional normal values and ASAT (SGOT) and /or ALAT (SGPT) =2.5 x UNL, alkaline phosphatase =2.5 x UNL
- •-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
- •Ability to swallow tablets
- •Signed informed consent
- •Patients must be willing and able to comply with the protocol for duration of the study
- •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
- •Malignancy of the rectum other than adenocarcinoma
- •Any unrested synchronous colon cancer
- •Other co-existing malignancy or malignancy within the last 5 years prior to treatment start, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
- •Clinically significant cardiovascular disease, for example CVA, myocardial infarction (within 12 months before treatment start), unstable angina, New York Heart Association (NYHA) > Class II congestive heart failure (CHF), arrhythmia requiring medication, or uncontrolled hypertension
- •Any arterial thromboembolic event within 6 months before start of study
- •Any serious venous thromboembolic event within 3 months before study start
- •Evidence of active peptic ulcer or upper GI bleeding
- •Evidence of bleeding diathesis or coagulopathy
- •Current or recent (within 10 days of first dose of study treatment) chronic use of aspirin (> 325 mg/day) or clopidrogel (> 75 mg/day)
- •Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes
- •History or evidence upon physical/neurological examination of CNS disease (unrelated to cancer) (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures
- •Serious, non-healing wound, ulcer or bone fracture
- •Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or lack of complete recovery
- •Acute intra abdominal inflammatory process
- •Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of nvestigational drug or puts the patient at high risk for treatment-related complications
- •Patients receiving a concomitant treatment with drugs interacting with capecitabin such as flucitosine, phenytoin, or warfarin
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •Known hypersensitivity to study drug
- •Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study
- •Life expectancy less than 3 months
- •Pregnant or lactating patient
- •Females with a positive or no pregnancy test unless childbearing potential can be otherwise excluded (amenorrheic for at least 2 years, hysterectomy or oophorectomy)
研究者
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