Phase II Trial Of Adjuvant 2'2'-Difluoro-2'-Deoxycytidine (Gemcitabine) And External Beam Radiation For The Treatment Of Resectable Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gemcitabine may make tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation therapy after surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with radiation therapy in treating patients who have undergone surgery to remove cancer of the pancreas.
详细描述
OBJECTIVES:
- Determine the time to disease progression, local control, and survival of patients with previously resected pancreatic cancer treated with adjuvant gemcitabine and radiotherapy.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 in the absence of disease progression or unacceptable toxicity.
Beginning at least 4 weeks after chemoradiotherapy, patients without disease progression and with less than 10% weight loss during study receive additional gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed invasive adenocarcinoma of the pancreas
- •Prior gross total resection via a pancreaticoduodenectomy (Whipple resection or total pancreatectomy) within the past 2 months
- •No clinical evidence of gross residual disease at time of surgery
- •No focally positive margins (tumor at the margin)
- •No unresected nodal disease or metastatic disease to the liver, peritoneal surfaces, or elsewhere
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •More than 6 months
- •Hematopoietic:
- •Granulocyte count greater than 1,500/mm3
- •Hemoglobin greater than 10 g/dL
- •Platelet count greater than 100,000/mm3
- •Bilirubin less than 2.0 mg/dL
- •Creatinine less than 2.0 mg/dL
- •Able to maintain adequate oral nutrition
- •Documented stable weight (no more than 5 lbs weight loss) for at least 2 weeks prior to study
- •No other malignancy within the past 2 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
- •Non-metastatic prostate cancer allowed if more than 2 year survival likely
- •No other serious medical or psychiatric illness that would preclude study or limit survival to less than 2 years
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent routine growth factors
- •Chemotherapy:
- •No prior chemotherapy for pancreatic cancer
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior abdominal radiotherapy for pancreatic cancer
- •See Disease Characteristics
排除标准
- 未提供