A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 227
- 主要终点
- Overall Survival Time
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.
详细描述
OBJECTIVES:
- Compare the overall survival and progression-free of patients with locally advanced, unresectable pancreatic cancer treated with gemcitabine with or without radiotherapy.
- Compare the objective response rate in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life (QOL) of patients treated with these regimens.
- Determine the effect of gemcitabine and radiotherapy on the QOL of patients with improved objective response rate and progression-free and overall survival.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs. 1) and weight loss within the past 6 months (less than 10% vs. 10% or more). Patients are randomized to 1 of 2 treatment arms.
Arm I (Gemcitabine alone):
- Induction: Patients receive gemcitabine intravenously (IV) over 30-60 minutes once weekly for 6 weeks followed by 1 week of rest.
- Consolidation: After the 1 week of rest, patients receive gemcitabine IV once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas
- •Locally advanced or regional (encompassable within the same radiotherapy portals)
- •Adenosquamous cancers are allowed
- •Unresectable disease
- •Measurable and/or non-measurable disease as determined by computed tomography (CT) scan or magnetic resonance imaging (MRI), which must be performed within 4 weeks prior to randomization.
- •ECOG Performance status of 0-1
- •Life expectancy >= 12 weeks
- •Adequate bone marrow reserve,liver and renal function within 2 weeks of randomization:
- •Absolute granulocyte count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 3 mg/dL (unless secondary to biliary obstruction or cholangitis)
- •Serum glutamic-oxaloacetic (AST) less than 5 times upper limit of normal (ULN)
- •Albumin greater than 2.5 g/dL
- •Creatinine no greater than 1.5 times ULN
- •Fertile patients must use effective contraception
- •Willing and able to attend follow-up visits
- •Concurrent enrollment on protocol ECOG-E1Y03 allowed
- •More than 4 weeks since prior investigational agents
排除标准
- •Candidate for surgical excision based on local extent of disease (e.g., T3, N1, M0)
- •Stage M1 disease
- •Small cell, mucinous cystadenocarcinoma, islet cell or papillary cystic histology
- •Pregnant or nursing
- •Active infection within within 4 weeks of randomization
- •Malignancy within the past 5 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score no greater than 7)
- •History of active collagen vascular disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma)
- •Signs or symptoms of peptic or duodenal ulcer disease
- •Concurrent serious systemic disorders that are incompatible with study participation
- •Prior chemotherapy for pancreatic cancer
- •Prior radiotherapy
- •Concurrent intensity modulated radiotherapy
研究组 & 干预措施
Gemcitabine
干预措施: Gemcitabine (Drug)
Gemcitabine + Radiation
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Overall Survival Time
时间窗: assessed every 3 months for 2 years, then every 6 months for year 3
Overall survival was defined as the time from randomization (registration) to death from any cause. Patients alive at last follow-up were censored. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients received treatment beyond 3 years were also followed for survival.
次要结局
- Progression-free Survival Time(assessed every 3 months for 2 years, then every 6 months for year 3)
- Overall Response(assessed at week 8, and every 3 months for 2 years, then every 6 months for year 3)