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Locally Advanced or Metastatic Pancreatic Adenocarcinoma

2022年7月28日 更新者:National Health Research Institutes, Taiwan

Phase II Trial of Biweekly S-1, Leucovorin and Gemcitabine in Elderly Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma

Multiple centers, uncontrolled, open-label, non-randomized single-arm study

研究概览

详细说明

To evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving GSL treatment, Primary objective: Overall tumor response rate (by RECIST criteria)

Secondary objectives:

Disease control rate (Objective response rate + stable disease ≧ 16 weeks) Time to tumor progression Progression-free survival Overall survival Clinical benefit response Quality of life Safety profile Biomarker of pancreatic cancer

研究类型

介入性

注册 (实际的)

49

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Taichung、台湾
        • China Medical University Hospital
      • Taipei、台湾
        • Chang-Gung Memorial Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

70年 及以上 (年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas.
  2. Patients have disease measurable or evaluable on x-ray, computed tomography scan, or physical examination.
  3. Patients have no history of prior chemotherapy for metastatic pancreatic cancer. Patients who had received chemotherapy as in an adjuvant or neoadjuvant setting which was completed at least 6 months before recurrence are eligible.
  4. Patients with prior radiotherapy are eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
  5. Baseline ECOG performance status is 2.
  6. Patients have life expectancy of at least 12 weeks.
  7. Patients have age 70 years.
  8. Patients have adequate organ function.
  9. Patients with biliary obstruction which is adequate drained before enrollment are eligible.
  10. Patients agree to have an indwelling venous catheter implanted.
  11. Women or men of reproductive potential should agree to use an effective contraceptive method.
  12. All patients must be informed of the investigational nature of this study and must sign written informed consents.

Exclusion Criteria:

  1. Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
  2. Patients with metastatic lesion in central nervous system.
  3. Patients with active infection.
  4. Patients with active cardiopulmonary disease or history of ischemic heart disease.
  5. Patients who have peripheral neuropathy > grade I of any etiology.
  6. Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator.
  7. Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Biweekly TS-1, Leucovorin and Gemcitabine (GSL)
Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 to 7 Leucovorin 60 mg/d, orally twice daily on day 1 to 7 Every 14 days as one cycle
Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 - 7; Leucovorin 60 mg/d, orally twice daily on day 1 - 7; Every 14 days as one cycle.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Progression-free survival (PFS)
大体时间:up to 5.0 months
The progression-free survival time for elderly patients with advanced pancreatic cancer
up to 5.0 months

次要结果测量

结果测量
大体时间
Overall tumor response rate
大体时间:up to 18 months
up to 18 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年4月3日

初级完成 (实际的)

2020年4月20日

研究完成 (实际的)

2020年4月20日

研究注册日期

首次提交

2018年4月18日

首先提交符合 QC 标准的

2018年6月5日

首次发布 (实际的)

2018年6月18日

研究记录更新

最后更新发布 (实际的)

2022年7月29日

上次提交的符合 QC 标准的更新

2022年7月28日

最后验证

2018年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

chemotherapy: TS-1, Leucovorin and Gemcitabine的临床试验

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