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临床试验/NCT02734680
NCT02734680Unknown不适用

Intraoperative Radiotherapy(IORT) Followed by Concurrent Chemoradiotherapy(CCRT) or Stereotactic Radiotherapy(SBRT) for Locally Advanced Pancreatic Cancer

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
Overal survival

研究概览

简要总结

The purpose of this study is to find the best model of combination of intraoperative radiotherapy(IORT) and postoperative radiochemotherapy for pancreatic cancer.

详细描述

The trial is funded by Cancer Foundation of China. The trial is prepared to be registered on the clinicaltrail.gov.

Quality assurance plan: every participant is enrolled or excluded by two practiced investigators. And two investigators participated in all steps of the trail, including the record of the data, and the investigators will compare the data. If the data is consistent, the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the workers of research and financial department of National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences.

Data check: the investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.

Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms.

Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information, and normal ranges if relevant.

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
Single (Outcomes Assessor)

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

入选标准

  • Diagnosed as locally advanced pancreatic cancer.
  • Cannot be treated by surgical resection.

排除标准

  • Treated by chemotherapy or radiotherapy before.
  • With distant organ metastasis.
  • Cannot tolerate surgery (Intraoperative radiotherapy)

研究组 & 干预措施

Concurrent chemoradiotherapy(CCRT) Group

Experimental

Concurrent chemoradiotherapy(CCRT) (Total dose: 46 Gy; Single dose: 2 Gy; Frequency: 23; Gemcitabine(GEM), 300 mg/m2 weekly); Followed by taking S-1 orally (40 mg/m2, bid on Day 1-28, Q42d)

干预措施: Concurrent chemoradiotherapy(CCRT) (Radiation)

Stereotactic Radiotherapy(SBRT) Group

Experimental

Stereotactic Radiotherapy(SBRT) (Total dose: 45 Gy; Single dose: 3 Gy; Frequency: 15) Followed by taking S-1 orally (40 mg/m2, bid on Day 1-28, Q42d)

干预措施: S-1 (Drug)

Concurrent chemoradiotherapy(CCRT) Group

Experimental

Concurrent chemoradiotherapy(CCRT) (Total dose: 46 Gy; Single dose: 2 Gy; Frequency: 23; Gemcitabine(GEM), 300 mg/m2 weekly); Followed by taking S-1 orally (40 mg/m2, bid on Day 1-28, Q42d)

干预措施: S-1 (Drug)

Stereotactic Radiotherapy(SBRT) Group

Experimental

Stereotactic Radiotherapy(SBRT) (Total dose: 45 Gy; Single dose: 3 Gy; Frequency: 15) Followed by taking S-1 orally (40 mg/m2, bid on Day 1-28, Q42d)

干预措施: Stereotactic Radiotherapy(SBRT) (Radiation)

结局指标

主要结局

Overal survival

时间窗: 2 years

OS

次要结局

  • Progression-free survival(2 years)
  • Local control rate(2 years)
  • Disease-specific survival(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chengfeng Wang

Director of Department of Abdominal Surgical Oncolgoy

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (1)

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