A Phase II Study of Concurrent Chemo-radiotherapy With Capecitabine for Unresectable Locally Advanced Pancreatic Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- all cause mortality
研究概览
简要总结
The only curative option for pancreatic cancer patients is surgery, but the patients within 20% of them are possible for a radical surgery. Accordingly, concurrent chemo-radiation therapy is generally used for palliation of unresectable pancreatic cancer patients. So far, the use of 5-fluorouracil (5-FU) was the traditional method of chemotherapy. However, these days, oral anti-cancer medicine, capecitabine(Xeloda®), was developed and considered as an alternative medicine of 5-fluorouracil (5-FU). Furthermore, according to the recent results of clinical trials, the clinical use of capecitabine(Xeloda®) with radiation therapy was proved to be very effective and safe. The purpose of this trial is to improve the therapeutic effects by using proton therapy and chemotherapy concurrently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •There is no evidence of metastatic disease in the major viscera and no peritoneal seeding
- •Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation
- •All malignant disease must be encompassable within a single irradiation field (15x15cm maximum)
- •All patients must have radiographically assessable disease
- •No previous irradiation to the planned field
- •Age of ≥18 years
- •performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score
- •Required Entry Laboratory Parameters WBC count ≥ 2,000/mm3;(ANC>1,000), hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 100,000/mm3; total bilirubin ≤ 3.0 mg/dL (Patients with elevated bilirubin due to obstruction should be stented and their bilirubin should be decreas ≤ 3.0 mg/dL prior to study entry); creatinine ≤ 3.0 mg/dL
- •Oral intake (including J-tube feeding) of ≥ 1,500 calories/day should be maintained.
排除标准
- •There is evidence of metastasis in the major viscera or peritoneal seeding.
- •Age of <18 years
- •Previous history of RT adjacent to planned field
- •poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
- •pregnant or breast feeding status
- •previous history of uncontrolled other malignancies within 2 years
研究组 & 干预措施
1
Primary objectives :
To evaluate the tumor response rate, local control rate and compliance (acute and late toxicity, esp. gastrointestinal tract toxicity) of concurrent chemo-radiotherapy with oral capecitabine in patients with unresectable locally advanced pancreatic carcinoma
Secondary objectives :
To evaluate the impact of concurrent chemo-radiotherapy with oral capecitabine in patients with unresectable locally advanced pancreatic carcinoma by analyzing the progression-free survival rate and overall survival rate.
干预措施: Capecitabine (Xeloda®) (Drug)
1
Primary objectives :
To evaluate the tumor response rate, local control rate and compliance (acute and late toxicity, esp. gastrointestinal tract toxicity) of concurrent chemo-radiotherapy with oral capecitabine in patients with unresectable locally advanced pancreatic carcinoma
Secondary objectives :
To evaluate the impact of concurrent chemo-radiotherapy with oral capecitabine in patients with unresectable locally advanced pancreatic carcinoma by analyzing the progression-free survival rate and overall survival rate.
干预措施: Localization, simulation and immobilization (Radiation)
结局指标
主要结局
all cause mortality
时间窗: two year
次要结局
未报告次要终点