NCT00085163已完成3 期
Multicenter, Double-Blind, Placebo-Controlled Randomized Phase III Study of Adjuvant Therapy With Celecoxib in Combination With Chemotherapy in Patients With Curatively Resected Stage III Colon Cancer
European Organisation for Research and Treatment of Cancer - EORTC36 个研究点 分布在 3 个国家开始时间: 2004年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 36
- 主要终点
- Disease-free survival as measured by Logrank every 3 months in year 1, every 6 months in years 2-3, and annually thereafter
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether fluorouracil and leucovorin are more effective with or without celecoxib in treating resected stage III adenocarcinoma (cancer) of the colon.
PURPOSE: This randomized phase III trial is studying celecoxib, fluorouracil, and leucovorin to see how well they work compared to fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer.
详细描述
OBJECTIVES:
Primary
- Compare disease-free survival of patients with curatively resected stage III adenocarcinoma of the colon treated with adjuvant fluorouracil and leucovorin calcium with or without celecoxib.
Secondary
- Compare the overall survival, the occurrence of new primary colon cancer, and the development of new polyps in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the colon
- •15 cm above anal verge
- •Stage III disease (any pT, N1-2, M0)
- •No rectal cancer
- •Must have undergone curative radical resection (R0 resection) within the past 6 weeks
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •AST ≤ 5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Cardiovascular
- •None of the following conditions within the past 6 months:
- •Myocardial infarction
- •Unstable angina
- •Symptomatic congestive heart failure
- •Serious uncontrolled cardiac arrhythmia
- •Cerebrovascular accident or transient ischemic attack
- •Deep vein thrombosis
- •Other significant thromboembolic event
- •No pulmonary embolism within the past 6 months
- •Gastrointestinal
- •No active gastric or duodenal ulceration within the past year
- •No gastrointestinal bleeding within the past year
- •No partial or complete bowel obstruction
- •No known chronic malabsorption
- •No active inflammatory bowel disease or chronic diarrhea (more than 4 stools/day)
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •No AIDS-related illness
- •No prior hypersensitivity to fluorouracil, leucovorin calcium, celecoxib, other COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides
- •No other severe acute or chronic medical condition or laboratory abnormality that would preclude study participation, study drug administration, or study results interpretation
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •No concurrent active infection
- •No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent sargramostim (GM-CSF) or molgramostim
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •No more than 4 weeks of concurrent orally/nasally inhaled steroids over a 6-month period
- •Concurrent mometasone (or fluticasone) allowed if patients require ≥ 4 weeks of inhaled steroid therapy
- 另有 14 项未显示
排除标准
- 未提供
结局指标
主要结局
Disease-free survival as measured by Logrank every 3 months in year 1, every 6 months in years 2-3, and annually thereafter
次要结局
- Toxicity as measured by CTC AE version 2.0 every 3 months in year 1, every 6 months in years 2-3, and annually thereafter
- Overall survival as measured by Logrank every 3 months in year 1, every 6 months in years 2-3, and annually thereafter
- Time occurrence of new primary colon cancer and new polyps as measured by Logrank every 3 months in year 1, every 6 months in years 2-3, and annually thereafter
研究者
研究点 (36)
Loading locations...
相似试验
已完成
3 期
Combination Chemotherapy as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer That Cannot Be Removed By SurgeryColorectal CancerNCT00303771Federation Francophone de Cancerologie Digestive282
已完成
2 期
Leucovorin, Fluorouracil, Cetuximab, and Oxaliplatin in Treating Patients With Stage IV Colorectal Cancer and Liver Metastases That Cannot Be Removed by SurgeryMetastatic CancerColorectal CancerNCT00544349Gustave Roussy, Cancer Campus, Grand Paris45
已完成
2 期
Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colon Cancer That Cannot Be Removed By SurgeryColorectal CancerNCT00321828NSABP Foundation Inc90
已完成
1 期
Arsenic Trioxide, Fluorouracil, and Leucovorin in Treating Patients With Stage IV Colorectal Cancer That Has Relapsed or Not Responded to TreatmentColorectal CancerNCT00449137University of Miami13
撤回
3 期
Surgery With or Without Hepatic Arterial Chemotherapy in Treating Patients With Liver CancerLocalized Resectable Adult Primary Liver CancerStage III Childhood Liver CancerNCT00238160Kyoto University