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临床试验/NCT04466189
NCT04466189Enrolling By Invitation不适用

Prospective Cohort Study for Identifying Factors Predicting Clinical Outcomes of Pancreatic Cancer Patients Treated With Proton Beam Therapy

National Cancer Center, Korea1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
120
试验地点
1
主要终点
Establish a cohort of Pancreatic cancer patients treadted with proton beam therapy.

研究概览

简要总结

Pancreatic cancer is one of the few cancers whose survival rate has not improved significantly due to high local recurrence and systemic metastasis despite advances in diagnosis and treatment over the past 40 years. And currently pancreatic cancer is the fifth leading cause of cancer-related death in Korea. For this reason, various anti-cancer therapies and radiotherapy have been tested to improve survival.

Due to recent advances in radiotherapy technology, proton beam therapy (PBT) is a promising treatment for pancreatic cancer because it can reduce radiation dose from surrounding normal tissue while maximizing radiation to tumor tissues due to the distinct physical properties of proton beam. Low toxicity have been reported. In addition, retrospective analysis of pancreatic cancer patients (n=37) who performed proton therapy (PBT) from June 2013 to July 2016 showed promising therapeutic performance and less toxicity (survival rate, 19.3 months; Grade ≥ 3 Toxicity, 0%). In addition, gene polymorphisms of several genes (CD44, CD166, XAF1, MMP9, MUC1/4, SMAD7, SMAD4 (DPC), RRM1, ERCC1, HER2, etc.) in pancreatic cancer have been reported to be associated with recurrence and prognosis.

详细描述

Pancreatic cancer is one of the few cancers whose survival rate has not improved significantly due to high local recurrence and systemic metastasis despite advances in diagnosis and treatment over the past 40 years. And currently pancreatic cancer is the fifth leading cause of cancer-related death in Korea. For this reason, various anti-cancer therapies and radiotherapy have been tested to improve survival.

Due to recent advances in radiotherapy technology, proton beam therapy (PBT) is a promising treatment for pancreatic cancer because it can reduce radiation dose from surrounding normal tissue while maximizing radiation to tumor tissues due to the distinct physical properties of proton beam. Low toxicity have been reported. In addition, retrospective analysis of pancreatic cancer patients (n=37) who performed proton therapy (PBT) from June 2013 to July 2016 showed promising therapeutic performance and less toxicity (survival rate, 19.3 months; Grade ≥ 3 Toxicity, 0%). In addition, gene polymorphisms of several genes (CD44, CD166, XAF1, MMP9, MUC1/4, SMAD7, SMAD4 (DPC), RRM1, ERCC1, HER2, etc.) in pancreatic cancer have been reported to be associated with recurrence and prognosis. Therefore, in this study, a prospective cohort of pancreatic cancer patients treated with proton beam therapy was established to analyze local control, survival, recurrence, toxicity, proton treatment plan information, gene expression information to analyze local control (LC), overall survival (OS), recurrence-free surival (RFS), and factors predicting treatment-related toxicity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pancreatic cancer patients scheduled to be proton beam therapy
  • Agreed to participate in this study

排除标准

  • Disagreed to participate in this study

结局指标

主要结局

Establish a cohort of Pancreatic cancer patients treadted with proton beam therapy.

时间窗: Up to 10 years

The primary outcome is to establish a prospective cohort of pancreatic cancer patients treadted with proton beam therapy. It is for exploring factors and models that predict local control, relapse, survival and treatment-related toxicity in patients with pancreatic cancer who have undergone proton therapy.

次要结局

未报告次要终点

研究者

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

Tae Hyun Kim

Principal Investigator

National Cancer Center, Korea

研究点 (1)

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