A Randomized Controlled Phase II Study on Intra-arterial Versus Intravenous Chemotherapy Infusion With Gemcitabine and Oxaliplatin for Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This study aims to explore the efficacy and safety of intra- arterial infusion of gemcitabine and oxaliplatin in locally advanced pancreatic cancer. This protocol is overseen by the Fudan University Institutional Review Board which has Federal Wide Assurance through the U.S. Department of Health & Human Services (Approved: April 25, 2002).
详细描述
Primary Outcome Measures:
To compare the overall survival (OS) in patients with locally advanced pancreatic cancer treated with transcatheter arterial infusion (TAI) of chemotherapeutics or systemic delivered chemotherapy.
Secondary Outcome Measures:
To compare the progression free survival (PFS), objective response rate (ORR), quality of life (QoL), and adverse effects of treating locally advanced pancreatic cancer patients with TAI or systemic chemotherapy.
Exploratory Outcome Measures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically/cytologically confirmed unresectable locally advanced pancreatic adenocarcinoma.
- •Measurable disease by RECIST criteria must be present.
- •Karnofsky Performance Status ≥ 70
- •Patients with adequate organ functions reflected by the laboratory criteria below:
- •Granulocytes ≥ 1,500/uL Hemoglobin ≥ 8.0 gm/dL Platelets ≥ 100,000/uL Serum creatinine < 2.0 mg/dL Bilirubin < 1.5 mg/dL SGPT < 2.5 x normal Alk Phos < 2.5 x normal
- •Prior local therapy, e.g., radiation, is allowed provided that at least 4 weeks washout time is given.
- •Patients with jaundice must have a biliary drainage decompression operation before recruitment.
- •Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal patients.
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Subject with metastatic disease.
- •Prior treatment with systemic chemotherapy.
- •Known allergies to the gemcitabine, oxaliplatin or iodine contrast agent.
- •Subject with Child-Pugh grade Class C hepatic impairment, active gastrointestinal bleeding, severe coagulation disorder that could not be corrected，or other contraindication for transcatheter infusion.
- •Untreated or uncontrolled deep vein thrombosis, arterial thrombosis of lower extremity, or aneurysm.
- •Concurrent infection requiring intravenous antibiotics.
- •Skin injury or infection of groin area, or other situation that not appropriate for femoral artery puncture.
- •Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV), active HIV infection/HIV disease, psychiatric disorders.
- •Known central nervous system involvement and leptomeningeal disease
- •Subject with previous or concurrent cancer that is distinct in primary site or histology from pancreatic adenocarcinoma except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.
- •Pregnant or lactating women.
研究组 & 干预措施
TAI chemotherapy
Patients in this arm will receive transcatheter arterial infusion of chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment.
干预措施: Transcatheter arterial infusion (Procedure)
TAI chemotherapy
Patients in this arm will receive transcatheter arterial infusion of chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment.
干预措施: Gemcitabine (Drug)
TAI chemotherapy
Patients in this arm will receive transcatheter arterial infusion of chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment.
干预措施: Oxaliplatin (Drug)
Chemotherapy
Patients in this arm will receive intravenous chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment.
干预措施: Intravenous chemotherapy (Procedure)
Chemotherapy
Patients in this arm will receive intravenous chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment.
干预措施: Gemcitabine (Drug)
Chemotherapy
Patients in this arm will receive intravenous chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Overall survival
时间窗: From date of randomization until the date of death, assessed up to 100 months.
次要结局
- Progression free survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.)
研究者
Zhiqiang Meng
Professor, MD, Ph D
Fudan University