NCT00335543已完成2 期
Preoperative Chemoradiation in Locally Resectable Adenocarcinoma of Pancreatic Head Without Metastasis
Interdisziplinare Arbeitsgruppe Gastrointestinaler Tumore der Deutschen Krebsgesellschaft34 个研究点 分布在 3 个国家目标入组 254 人开始时间: 2003年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 254
- 试验地点
- 34
- 主要终点
- Median survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in 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 chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet know whether giving chemotherapy together with radiation therapy before surgery is more effective than surgery alone in treating pancreatic cancer.
PURPOSE: This randomized phase II trial is studying how well giving gemcitabine and cisplatin together with radiation therapy before surgery works compared to surgery alone in treating patients with localized pancreatic cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine whether neoadjuvant chemoradiotherapy comprising gemcitabine hydrochloride, cisplatin, and radiotherapy is better than immediate surgery, in terms of median survival, in patients with locally resectable adenocarcinoma of the pancreatic head.
Secondary
- Compare 3-year survival rate in patients treated with these regimens.
- Compare R0 resection rate in these patients.
- Compare the rate of medium and high toxicity events in these patients.
- Compare the rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies.
- Compare the rate of different regression gradings in resected tumor specimens.
- Compare the quality of life of 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed adenocarcinoma of the pancreatic head
- •No tumors of the body or tail, as defined by a tumor lying between the left border of the superior mesenteric vein and the left border of the aorta and/or the left border of the aorta and the hilum of the spleen
- •Locally resectable disease by CT scan
- •Major vessels (e.g., portal vein, confluence of mesenteric and splenic vein, superior mesenteric artery, celiac trunk, splenic artery, hepatic artery, or superior mesenteric vein) maximally enclosed ≤ 180° by the tumor
- •No infiltration of extrapancreatic organs except the duodenum
- •No carcinoma of the ampulla of Vater
- •No metastasis
- •No peritoneal carcinoma
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 70-100%
- •Creatinine clearance > 70 mL/min
- •Creatinine < 1.5 mg/dL
- •Platelet count > 100,000/mm³
- •No liver cirrhosis
- •Not pregnant
- •No New York Heart Association class III or IV heart disease
- •No respiratory insufficiency
- •No grade III or IV cardiac arrhythmias
- •No pathology on EKG
- •No other severe cardiopulmonary disease
- •No HIV infection
- •No other disease that renders the patient unsuitable for one treatment option
- •No other malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or other cancer for which the patient was treated with surgery only and has been in complete remission for ≥ 10 years
- •PRIOR CONCURRENT THERAPY:
- •At least 3 months since prior participation in another clinical trial
- •No prior or other concurrent treatment for carcinoma of the pancreas
排除标准
- 未提供
结局指标
主要结局
Median survival
次要结局
- 3-year survival rate
- R0 resection rate
- Rate of medium and high toxicity events
- Rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies
- Rate of different regression gradings in resected tumor specimens
- Quality of life before, during, and after therapy
研究者
研究点 (34)
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