NCT00274898Unknown2 期
Phase II Randomized Study Evaluting the Effect of Celecoxib as Maintenance Treatment of Stage IIIb Non-Small Cell Lung Cancer That Reponded or is Stable After Radiochemotherapy
GERCOR - Multidisciplinary Oncology Cooperative Group30 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2004年5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
- 入组人数
- 80
- 试验地点
- 30
- 主要终点
- Time to progression
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving celecoxib after radiation therapy and chemotherapy may kill any tumor cells that remain after radiation therapy and chemotherapy. Sometimes, after radiation therapy and chemotherapy, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.
PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to observation in treating patients who have undergone radiation therapy and chemotherapy for stage II or stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare the time to progression in patients with stage II-IIIB non-small cell lung cancer treated with celecoxib vs observation after treatment with chemoradiotherapy.
Secondary
- Compare the 2-year survival rate of patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare weight changes and objective response in patients treated with these regimens.
- Compare tolerability of these regimens in these patients.
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 75 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 non-small cell lung cancer meeting ≥ 1 of the following criteria:
- •Stage IIIB disease
- •Stage II or IIIA disease, meeting the following criteria:
- •Considered nonresectable
- •Pleural effusion present
- •Measurable disease
- •Must have received a prior regimen of radiotherapy and chemotherapy comprising docetaxel and carboplatin
- •Tumor volume must be able to be encompassed in the radiation field
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy > 12 weeks
- •Cardiac function compatible with radiotherapy
- •Neutrophil count ≥ 2,000/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 10 g/dL
- •Creatinine ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.25 times ULN
- •AST and ALT ≤ 1.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Not pregnant or nursing
- •No other malignancy in the past 10 years except basal cell skin cancer or carcinoma in situ of the cervix
- •No active infection
- •No inflammatory bowel disease
- •No severe congestive heart failure
- •No severe hepatic disease defined as albumin < 25 g/L or Child-Pugh score ≥ 10
- •No severe renal disease defined as creatinine clearance < 30 mL/min
- •No known hypersensitivity to sulfonamides, the study or it's excipients, or polysorbate 80
- •No known hypersensitivity of NSAIDs, salicylic acid, or cyclo-oxygenase-2 inhibitors
- •No familial, social, geographical, or psychological condition that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 30 days since participation in another clinical study
- •More than 1 month since prior therapy for gastrointestinal ulcers
- •No concurrent fluconazole, ketoconazole, lithium, or dextromethorphan
- •No other concurrent anticancer treatment including chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic response modifier therapy
- •No concurrent aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)
- •Low-dose aspirin or NSAIDs for a duration of ≤ 1 week during the past 3 months allowed
排除标准
- 未提供
结局指标
主要结局
Time to progression
次要结局
- 2-year survival rate
- Quality of life
- Weight changes
- Objective response
- Tolerability
研究者
研究点 (30)
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