NCT01396681已完成2 期
Phase Ⅱ Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Gemcitabine in Patients With Resected Pancreatic Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- recurrence/metastasis free survival
研究概览
简要总结
This is a phase Ⅱ Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Gemcitabine in Patients With Resected Pancreatic Cancer.
详细描述
The primary study objective is to evaluate recurrence/metastasis free survival at 12 months with postoperative adjuvant treatment incorporating gemcitabine plus cisplatin chemotherapy followed by chemoradiation with gemcitabine followed by maintenance chemotherapy with gemcitabine.
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
- •Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
- •Be between 18 and 75 years of age.
- •Patients who are ambulatory and have a ECOG Performance Status of 0-
- •Histologically confirmed pancreatic adenocarcinoma.
- •Received curative resection (R0 resection) of stage 1b ~ 2b pancreatic cancer (according to AJCC staging, 6th edition - Appendix 1), no more than 8 weeks has elapsed since the time of operation.
- •WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm
- •Platelet count at least 100,000/mm
- •Bilirubin less than 2.0 mg/dL, AST less than 3 times upper limit of normal (ULN).
- •Serum creatinine no greater than 1.5 times ULN.
排除标准
- •Pregnant or lactating woman.
- •Woman of childbearing potential with either a positive or no pregnancy test at baseline.
- •Woman of childbearing potential not using a reliable and appropriate contraceptive method (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
- •Sexually active males unwilling to practice contraception during the study.
- •Prior chemotherapy for the treatment of pancreatic carcinoma.
- •Radiotherapy incorporating radiation fields of more than 25% of active bone marrow.
- •History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
- •Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication).
- •Participation in any investigational drug study within four weeks preceding the start of study treatment.
- •Serious, uncontrolled, intercurrent infection(s).
- •Other significant medical conditions that would, in the judgment of the investigator, make administration of study drug unsafe.
结局指标
主要结局
recurrence/metastasis free survival
时间窗: 24 months
次要结局
- recurrence free survival(24 months)
- Overall survival(24 months)
- 2 year survival rate(24 months)
- Safety and tolerability(24 months)
研究者
研究点 (4)
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