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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04466189
Study type Observational
Source National Cancer Center, Korea
Contact
Status Enrolling by invitation
Phase
Start date September 21, 2018
Completion date August 31, 2028

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