PER-060-06已完成未知
PHASE III, RANDOMIZED, STUDY, THAT COMPARES 5-FU, LEUCOVORIN AND OXALIPLATIN AND BEVACIZUMAB IN PATIENTS WITH STADIUM II OF CANCER OF COLON WITH HIGH RISK OF RECURRENCE FOR THE PROGNOSTIC VALUE OF MOLECULAR MARKERS DETERMINED PROSPECTIVELY
EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),0 个研究点目标入组 0 人开始时间: 2007年1月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •1. The distal extent of the tumor must be >/= 12cm from the anal verge.
- •2. Patients must have a paraffin-embedded tumor specimen available for the evaluation of risk that is less than 50 days old.
- •3. Histologically confirmed adenocarcinoma of the colon that meets Stage II carcimona criteria.
- •4. >/= 8 lymph nodes must have been evaluated and reported.
- •5. Patients with prior malignancies are eligible if they have been disease free for >/= 5 years and are deemed by their physician to be at low risk of recurrence.
- •6. Patients must be >/= 18 years old.
- •7. Patients must have ECOG performance status of 0-2.
- •8. Patient must, within 2 weeks prior to randomisation, have: a) Postoperative absolute granulocyte count of >/=1500/mm3. b) Postoperative platelet count of >/= 100,000/mm3. c) Postoperative evidence of adequate hepatic function. d) Postoperative evidence of adequate renal function
排除标准
- •1. A history of isolated, distant, non-contiguous intra-abdominal metastases.
- •2. A presence of complete obstruction or perforation of the bowel.
- •3. Systemic or radiation therapy initiated for this malignancy.
- •4. Any significant bleeding that is not related to the primary colon tumour within 6 months prior to study entry.
- •5. Gastroduodenal ulcer(s) determined to be active by endoscopy.
- •6. Patients with a history of hypertension must have a measurement of <150/90 and be on a stable regimen of anti-hypertensive therapy.
- •7. A serious or non-healing wound, skin ulcers or bone fractures.
- •8. Concomitant halogenated antiviral agents.
- •9. Clinically significant peripheral neuropathy at the time of step 2 randomization.
- •10. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization.
- •11. Core biopsy or other minor procedure, excluding placement of a vascular access device, within 7 days prior to randomization.
- •12. Anticipation of a need for major surgical procudure(s) during the course of the study.
- •13. Patients must begin adjuvant treatment no less than 28 days and no more than 60 days from surgery.
- •14. Eligible patients of reproductive potential (both sexes) must agree to use an accepted and effective method of contraceptive during study therapy and for at least 3 months after the completion of bevacizumab.
- •15. Women must not be pregnant or breast-feeding at study entry.
- •16. Patients with PT (INR) >1.5 are not eligible, unless the patient is on full-dose anticoagulants.
- •16. Patients with non-malignant systemic disease that would preclude any of the study therapy drugs are not elegible.
- •17. A hisotory of Transient Ischemic Attack (TIA) or cerebrovascular accident (CVA).
- •18. A history of the following within the 12 months of study entry: a) Arterial thromboembolic events. b) Unstable angina. c) Myocardial Infarction. d) Symptomatic peripherial vascular disease. e) Psychiatric or addictive disorders or other conditions that would preclude them from meeting the study requirements.
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