EUCTR2011-005296-16-DE进行中（未招募）1 期
Capecitabine and bevacizumab with radiotherapy after 3-6 months chemotherapy for patients with oligometastatic colorectal cancer (OLGA trial)
niversity Medical Center Hamburg-Eppendorf0 个研究点目标入组 72 人开始时间: 2012年6月21日最近更新:
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
- 72
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) Patients with histologically confirmed diagnosis of stage IV
- •(UICC) colorectal cancer
- •2) Oligometastatic disease, defined as at least one
- •measurable lesion with size > 1 cm to a maximum of 3
- •sites and 5 lesions. (RECIST v1.1)
- •3) Patients being neither progressive nor resectable after
- •3-6 months of first line chemotherapy with
- •bevacizumab.
- •4) Maximum treatment interruption after induction therapy of 6
- •5) ECOG Performance status = 1
- •6) Life expectancy > 3 months
- •7) Age =18 years.
- •8) Haematologic function: ANC = 1.5 x 10^9/L, platelets = 75 x 10^9/L
- •9) INR <1.5 within 7 days prior to starting study treatment.
- •aPTT < 1.5 x ULN within 7 days prior to starting study
- •10) Adequate liver function as measured by serum
- •transaminases (AST & ALT) = 5 x ULN and total bilirubin
- •= 1.5 x ULN
- •11) Adequate renal function: Serum creatinine = 1.5 x ULN
- •12) Signed, written informed consent
- •13) Ability to swallow tablets
- •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 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1) Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study.
- •2) Prior radiotherapy for metastatic lesions (prior radiotherapy for primary tumor allowed if followed by complete resection and no sign for local recurrence at the time of enrolment).
- •3) Pre History or evidence upon physical/neurological examination of CNS disease (unrelated to cancer) (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures.
- •4) Fertile women (< 2 years after last menstruation) and women of childbearing potential unwilling or unable to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel or surgically sterile).
- •5) Pregnancy or lactation.
- •6) Positive serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women < 2 years after the onset of menopause. Note: a negative test has to be reconfirmed by a urine test, should the 7-day window be exceeded.
- •7) Past or current history (within the last 2 years prior to treatment start) of other malignancies except metastatic colorectal cancer (patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
- •8) Known DPD-insufficiency
- •9) Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > 4 loose stools per day)
- •10) Serious, non-healing wound, ulcer or bone fracture.
- •11) Evidence of bleeding diathesis or coagulopathy.
- •12) Urine dipstick for proteinuria =2+. If urine dipstick is = 2+, 24-hour urine must demonstrate = 1 g of protein in 24 hours for patient to be eligible.
- •13) Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first treatment with study medication.
- •14) Clinically significant cardiovascular disease, for example CVA, myocardial infarction (= 12 months before treatment start), unstable angina pectoris, NYHA Class II CHF, arrhythmia requiring medication, or uncontrolled hypertension.
- •15) 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 an investigational drug or puts the patient at high risk for treatment-related complications.
- •16) Concomitant therapy with sorivudin or chemical analogues like brivudin
- •17) Known hypersensitivity or contraindication to the drugs used in the trial (eg: capecitabine, bevacizumab)
- •18) Inability or unwillingness to comply with the protocol.
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