NCT00075556Unknown2 期
Phase II Study Of Radiotherapy And Capecitabine As Pre-Operative Treatment In Patients With Colorectal Cancer
GERCOR - Multidisciplinary Oncology Cooperative Group24 个研究点 分布在 1 个国家开始时间: 2002年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 24
- 主要终点
- Objective tumor response rate
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well neoadjuvant radiation therapy and capecitabine work in treating patients who are undergoing surgery for stage III or stage IV colorectal adenocarcinoma.
详细描述
OBJECTIVES:
Primary
- Determine the objective tumor response rate in patients with stage III or IV colorectal adenocarcinoma treated with neoadjuvant radiotherapy and capecitabine.
Secondary
- Determine the tolerance profile of this regimen in these patients.
- Determine the rate of preservation of functional integrity of the anal sphincter in patients treated with this regimen.
- Compare the conversion rate from the effects of mutilating surgery vs surgery with sphincter preservation in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 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:
- •Histologically or cytologically confirmed colorectal adenocarcinoma
- •Clinical stage T3, T4, N+
- •Measurable disease
- •Awaiting surgery and likely to benefit from neoadjuvant radiotherapy
- •PATIENT CHARACTERISTICS:
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST and ALT no greater than 2.5 times ULN
- •No hepatic condition that would interfere with study medication
- •Creatinine clearance at least 80 mL/min
- •No renal condition that would interfere with study medication
- •Cardiovascular
- •No serious cardiac failure with the past year
- •No myocardial infarction within the past year
- •No cardiac insufficiency
- •No angina
- •No uncontrolled arrhythmia
- •No uncontrolled hypertension
- •Gastrointestinal
- •No superior intestinal tract malfunction
- •No malabsorption syndrome
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No concurrent serious infection
- •No other serious illness
- •No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
- •No metabolic condition that would interfere with study medication
- •No dementia or altered mental status
- •No psychiatric illness that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for colorectal cancer
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy for colorectal cancer
- •Not specified
- •More than 30 days since prior participation in another clinical study
排除标准
- 未提供
结局指标
主要结局
Objective tumor response rate
次要结局
- Tolerability
- Rate of preservation of functional integrity of the anal sphincter
- Comparison of the conversion rate from the effects of mutilating surgery vs surgery with sphincter preservation
研究者
研究点 (24)
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