EUCTR2010-020379-22-IT进行中（未招募）不适用
Phase II study of hypofractionated radio-chemotherapy with gemcitabine plus oxaliplatin for unresectable nonmetastatic locally advanced pancreatic cancer. - IRST 157.01
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with histologically or cytologically confirmed diagnosis of pancreatic cancer are candidates for the trial. • Stage III disease (AJCC TNM 6th edition, 2002). Inoperable disease, by radiological and surgical evaluation; • Age >18 years and =75 years. • Life expectancy of greater than 12 weeks. • ECOG performance status 0-2 (see Appendix A). • Presence of at least of one measurable lesion in agreement to RECIST criteria • Patients must have normal organ and marrow function as defined below: - Leukocytes >3,000/?L - Absolute neutrophil count >1,500/?L - Platelets >100,000/?L - Total bilirubin < 1.5 X institutional upper limit of normal - AST (SGOT)/ALT (SGPT) <2.5 X institutional upper limit of normal (= 5 in patients with liver metastases) - Creatinine < 1.5 X institutional upper limit of normal • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. • Ability to understand and the willingness to sign a written informed consent document.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who have had any chemotherapy or radiotherapy prior to entering the study; • Stage IV disease; • Participation in another clinical trial with any investigational agents within 30 days prior to study screening. • Previous malignancy except cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors, or other malignancies curatively treated >5 years before study entry. • History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and oxaliplatin or other agents used in the study. • Active brain or leptomeningeal disease • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
研究者
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