NCT00043004终止2 期
CLOCC Trial (Chemotherapy + Local Ablation Versus Chemotherapy) Randomized Phase II Study Of Local Treatment Of Liver Metastases By Radiofrequency Combined With Chemotherapy Versus Chemotherapy Alone In Patients With Unresectable Colorectal Liver Metastases
European Organisation for Research and Treatment of Cancer - EORTC85 个研究点 分布在 10 个国家目标入组 119 人开始时间: 2002年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 119
- 试验地点
- 85
- 主要终点
- Survival rate as measured by Kaplan Meier method at 30 months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread by blocking blood flow. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. It is not yet known if chemotherapy is more effective with or without radiofrequency ablation in treating liver metastases.
PURPOSE: This randomized phase II trial is studying combination chemotherapy, bevacizumab, and radiofrequency ablation to see how well they work compared to combination chemotherapy and bevacizumab alone in treating unresectable liver metastases in patients with colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Compare the 30-month overall survival rate of patients with unresectable liver metastases secondary to colorectal adenocarcinoma treated with chemotherapy and bevacizumab with or without radiofrequency interstitial ablation.
Secondary
- Compare overall survival of patients treated with these regimens.
- Compare quality of life of patients treated with these regimens.
- Determine the health economics associated with this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Unresectable liver metastases secondary to colorectal adenocarcinoma, including:
- •Metastases that cannot be radically resected due to size, location, or number of deposits
- •Metastases invading right and left branches of hepatic artery or portal vein
- •Metastases extended to the 3 main hepatic veins
- •No detectable extra-hepatic disease
- •Fewer than 10 metastatic deposits on liver
- •Total metastatic involvement of liver no more than 50%
- •Adequate treatment of all metastatic lesions deemed possible either by radiofrequency interstitial ablation (RFA) alone or by a combination of resection of resectable lesions and RFA of the remaining unresectable lesions
- •Maximum diameter of 4 cm for lesions to be treated with RFA
- •No maximum diameter of lesions to be resected as long as negative resection margins are obtainable
- •If synchronous liver metastases, must have undergone prior resection of primary tumor
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •No bleeding disorder or coagulopathy or need for full-dose anticoagulation
- •Bilirubin less than 3 times upper limit of normal (ULN)
- •Alkaline phosphatase less than 3 times ULN
- •Creatinine less than 2 times ULN
- •Protein < 0.5 g/24 hr urine collection if proteinuria positive by dipstick
- •Cardiovascular
- •No uncontrolled congestive heart failure
- •No uncontrolled angina pectoris
- •No uncontrolled hypertension
- •No uncontrolled arrhythmia
- •No myocardial infarction within the past 12 months
- •No cerebrovascular accident or transient ischemic attack within the past 6 months
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No greater than grade 1 peripheral neuropathy
- •No significant neurologic or psychiatric disorder
- •No active infection
- •No contraindication to the use of fluorouracil, leucovorin calcium, oxaliplatin, or bevacizumab
- •No other malignancy within the past 10 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy except for metastatic disease confined to the liver
- •Prior fluorouracil, leucovorin calcium, and oxaliplatin allowed if administered for at least 3 courses (2 weeks each) but no longer than 3 months with at least stabilization of disease achieved
- •Prior adjuvant chemotherapy for primary cancer allowed except for patients who received oxaliplatin and have been diagnosed with metastatic disease within 12 months after completion of adjuvant treatment
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •More than 28 days since major surgery or open biopsy past 28 days
- 另有 3 项未显示
排除标准
- 未提供
结局指标
主要结局
Survival rate as measured by Kaplan Meier method at 30 months
次要结局
- Overall survival as measured by Logrank every 3 months for 30 months then every 6 months thereafter
- Progression-free survival as measured by Logrank every 3 months for 30 months then every 6 months thereafter
- Toxicity as measured by CTC version 2.0 every 3 months for 30 months then every 6 months thereafter
- Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) version 3.0 at baseline, weeks 6, 12, 18, and 24, every 3 months for years 1-2 after start of treatment, then every 6 months thereafter
- Response to treatment (arm II) as measured by RECIST criteria from start of treatment until disease progression
研究者
研究点 (85)
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