Randomized Phase II/III Study Comparing Gemcitabine Followed by Gemcitabine Plus Concomitant Radiation (50.4 Gy) Versus Control After Curative Pancreaticoduodenectomy for Pancreatic Head Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 59
- 主要终点
- Feasibility of full completion of treatment as measured by the number of patients completing treatment 1 month after treatment in phase II
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving gemcitabine together with radiation therapy is more effective than gemcitabine alone following surgery in treating pancreatic cancer.
PURPOSE: This randomized phase II/III trial is studying how well giving gemcitabine together with radiation therapy works and compares it to gemcitabine alone in treating patients who have undergone surgery for pancreatic cancer.
详细描述
OBJECTIVES:
Phase II:
- Determine the feasibility of gemcitabine followed by chemoradiotherapy with gemcitabine vs gemcitabine alone after prior curative resection in patients with pancreatic head adenocarcinoma.
- Compare the tolerability of these regimens, in terms of acute and late toxicity, in these patients.
Phase III:
- Compare the disease-free and overall survival of patients treated with these regimens .
- Compare the quality of life of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Determine the sites of recurrence 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
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed pancreatic head adenocarcinoma
- •Prior pancreaticoduodenectomy required
- •Documented histological examination of surgical margins (R0), including retroperitoneal margin
- •Performed within the past 8 weeks
- •Any number of lymph nodes (less than 10 OR 10 or more) allowed
- •No periampullary cancer
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-2 OR
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC greater than 3,500/mm^3
- •Platelet count greater than 150,000/mm^3
- •Hemoglobin greater than 9.0 g/dL
- •Bilirubin less than 1.5 times normal
- •AST and ALT less than 3.0 times normal
- •Creatinine less than 1.2 mg/dL
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent immunotherapy
- •Chemotherapy
- •No prior chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy
- •See Disease Characteristics
- •Recovered from prior surgery
- •No other concurrent anticancer agents
排除标准
- 未提供
结局指标
主要结局
Feasibility of full completion of treatment as measured by the number of patients completing treatment 1 month after treatment in phase II
Tolerability in terms of acute toxicity as measured by NCI-CTC v2.0 1 month after completion of treatment in phase II
Tolerability in terms of late toxicity as measured by EORTC and RTOG 1 month after completion of treatment in phase II
Overall survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter in phase III
次要结局
- Disease-free survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter
- Acute toxicity as measured by NCI-CTC v2.0 every 3 months in years 1-2, and every 6 months thereafter
- Late toxicity as measured by EORTC and RTOG every 3 months in years1-2, and every 6 months thereafter
- Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) v3.0 and EORTC QLQ PAN-26 every 3 months in years 1-2 and every 6 months thereafter