Randomized Phase II Study Comparing Gemcitabine/S-1 Combination Chemoradiotherapy With Gemcitabine/S-1 Combination Chemotherapy for Unresectable Locally Advanced Pancreatic Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Two year survival rate
研究概览
简要总结
The purpose of this study is to evaluate the clinical effectiveness of Gemcitabine/S-1 combination chemoradiotherapy with Gemcitabine /S-1 combination chemotherapy for unresectable locally advanced pancreatic cancer.
详细描述
When cancer develops outside of the pancreas from within the anatomical placement of the pancreas itself, it becomes difficult to excise in most cases. Generally, most pancreatic cancers are already unresectable at the time of diagnosis when we have recognized infiltration of over 1/2 the circumference of major arteries such as the celiac artery and super mesenteric artery in particular.
In comparison with advanced pancreatic cancer with distant metastases, it is not easy to treat unresectable locally advanced pancreatic cancer, even when performing standard gemcitabine monotherapy. In the case of unresectable locally advanced pancreatic cancers without distant metastases, we are left with the choice of whether or not to perform radiation therapy. This decision remains unsolved worldwide, despite the continuing efforts of researchers to bring an end to the clinical doubt.
We will report our results as well as the problems of combining treatments with chemoradiotherapy, using the novel anticancer agent gemcitabine as well as/or S-1, not 5FU, predominantly from our own clinical trials on this occasion.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer.
- •Patients who confirmed unresectable locally advanced pancreatic cancer with the criteria below.
- •Involving over 1/2 circumference of major artery (SMA/CA). (Under 1/2 that was borderline lesion.)
- •Involving over the merging section of portal-SMV.
- •No distal metastasis with diagnostic imaging.
- •Confirmed by CT image performed with in four weeks before registration.
- •Performance Status:0-1(ECOG)
- •Patients of age =>20 and 80>
- •sufficient organ functions
- •neutrophils>=1,500/mm3
- •platelets>=100,000/mm3
- •hemoglobin>=9.0g/dl
- •AST(GOT)/ALT(GPT) <=150IU
- •total bilirubin <=2.0mg/dl, (or <=3.0mg/dl if biliary drainage were present)
- •serum creatinine <= 1.2mg/dl
- •creatinine clearance>=60ml/min
- •Life expectancy more than 3 months.
- •Written informed consent.
排除标准
- •Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings.
- •Watery diarrhea
- •Severe infection
- •Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc)
- •Massive pleural or abdominal effusion.
- •Metastasis to central nervous system.
- •Active synchronous or metachronous malignancy other than carcinoma in situ.
- •Regular use of flucytosine, fenitoin or warfarin
- •Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
- •Severe mental illness
- •Patients who are judged inappropriate for the entry into the study by the investigator.
研究组 & 干预措施
Gemcitabine, S-1, radiotherapy
Gemcitabine 600mg/m2 on Day 1 and 8, every 3 weeks. S-1 60-100mg/day on Day 1 to 14, every 3 weeks with radiotherapy 50.4Gy in 28 fractions
干预措施: gemcitabine, S-1, radiotherapy (Drug)
结局指标
主要结局
Two year survival rate
时间窗: 2 years
次要结局
- Progression free survival（PFS）(4 years)
- Adverse events(4 years)
- Response rate(4 years)
- Overall Survival (OS)(4 years)
研究者
Tatsuya Ioka
Assistant director
Osaka Medical Center for Cancer and Cardiovascular Diseases