ACTRN12610000270011已完成3 期
Randomized phase III trial to compare progression free survival in patients with metastatic colorectal cancer receiving irinotecan in combination with capecitabine or fluorouracil (5-FU)/leucovorin (LV) and bevacizumab: (xeliri-bevacizumab vs folfiri-bevacizumab) as first-line treatment. A study of the Hellenic Cooperative Oncology Group (HeCOG)
Hellenic Cooperative Oncology Group0 个研究点目标入组 309 人开始时间: 2010年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 309
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Histologically or cytologically documented locally advanced or metastatic colorectal cancer
- •2.Two-dimensional measurable disease at least at one site, not previously irradiated (newly emerged disease at previously irradiated sites is acceptable). Ascites and pleural fluid are not considered measurable disease.
- •3. The diameter of one measurable lesion should be (at least one dimension)>=15 mm
- •4. No previous administration of chemotherapy (only neoadjuvant or adjuvant chemotherapy completed at least 4 months before patient enrollment in the protocol is acceptable).
- •5. Time between other anticancer treatments and patient enrollment should be:>= 4 weeks for major surgical intervention · >= 4 weeks for radiotherapy
- •6. Age>=18 years and performance status ECOG (Eastern Cooperative Oncology Group) 0-2
- •7. Expected life span > 3 months
- •8. Written informed consent
- •9. Adequate bone marrow function:
- •Hemoglobin >= 10 gr/dL
- •White blood cell >= 4 x 10^9/ L
- •Neutrophils >= 2 x 10^9/ L
- •Platelets >= 100 x 10^9/ L
- •10. Adequate hepatic and renal function
- •Total bilirubin <= 1.5 x UNL
- •Serum glutamic oxaloacetic transaminase (SGOT) <= 2.5 x UNL
- •Serum glutamic pyruvic transaminase (SGPT)<= 2.5 x UNL
- •Alkaline phosphates <= 2.5 x UNL
- •Creatinine <= 1.5 x UNL
- •11. In case of liver metastases:
- •Total bilirubin <= 2.5 x UNL
- •Serum glutamic oxaloacetic transaminase (SGOT) <= 5.0 x UNL
- •Serum glutamic pyruvic transaminase (SGPT) <= 5.0 x UNL
- •Alkaline phosphatase <= 5.0 x UNL
- •12. In case of bone metastases:
- •Alkaline phosphatase <= 10.0 x UNL
- •UNL: Upper normal limit of approved normal values.
排除标准
- •1.Malignant tumors other than colorectal adenocarcinoma
- •2.History of other malignant disease, excluding non-melanoma cancer of the skin and in-situ cervical cancer
- •3.Concomitant irradiation of a measurable lesion
- •4.Other concomitant anticancer treatment
- •5.Concomitant (or in the last 4 weeks before patient enrollment) administration of other investigational drugs
- •6.Measurable liver lesion affecting >50% of organ function
- •7.Other serious concomitant diseases or compromised general condition, including major neurological and psychiatric disorders 8.Severe cardiac disease (congestive heart failure, symptomatic coronary insufficiency, history of myocardial infarction in the last 6 months, uncontrolled high-risk arterial hypertension or uncontrolled cardiac arrhythmia)
- •9.Uncontrolled metabolic disorders (unstable diabetes mellitus or other contraindications to corticosteroids) or serious uncontrolled active infection
- •10.Brain metastases and patients with bone metastases or serosal effusions as the only sites of disease
- •11.Inflammatory bowel disease or loss of proximal gastrointestinal tract integrity or malabsorption syndrome
- •12.Complete or partial bowel obstruction
- •13. Current history of chronic diarrhea
- •14.The patient had a major surgical operation in the last 4 weeks before enrollment and has not recovered yet
- •15.Pregnant or breastfeeding women
- •16.Female fertile patients not using an appropriate form of contraception
- •17.Patients with allo-transplanted organs 18.Inadequate follow-up because of psychological, socioeconomic, or other factors.
研究者
相似试验
尚未招募
2 期
prevention of lymphedema after breast cancer surgeryCTRI/2019/07/020436AIIMS New Delhi
尚未招募
不适用
A prospective randomized controlled trial comparing between endoscopic balloon dilation and endoscopic sphincterotomy for the removal of common bile duct stonesKCT0001852Presbyterian Medical Center100
尚未招募
不适用
Study to compare an injection given in lower back with injections given in outer layer of abdomen in children undergoing lower abdominal surgery for pain scores.CTRI/2017/12/010988Post graduate institute of medical education and research
尚未招募
2 期
A prospective randomized controlled trial comparing antecolic route and retroclic route with Roux-Y reconstruction after distal gastrectomy.Gastric cancerJPRN-UMIN000012062agoya University Graduate School of Medicine120
已完成
4 期
A Prospective Randomized Controlled Trial of Preoperative Transarterial Chemoembolization for Resectable Large Hepatocellular CarcinomaCancer - LiverHepatocellular carcinomaACTRN12608000577314Eastern Hepatobiliary Surgery Hospital100