Viewing Study NCT04466124



Ignite Creation Date: 2024-05-06 @ 2:55 PM
Last Modification Date: 2024-10-26 @ 1:39 PM
Study NCT ID: NCT04466124
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2020-07-13
First Post: 2020-07-06

Brief Title: Prospective Cohort Study of Liver Cancer Patients Treated With Proton Beam Therapy
Sponsor: National Cancer Center Korea
Organization: National Cancer Center Korea

Study Overview

Official Title: Prospective Cohort Study for Identifying Factors Predicting Clinical Outcomes of Liver Cancer Patients Treated With Proton Beam Therapy
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2020-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Liver cancer is the fourth most common malignant tumor in Korea and it is the third most common cause of cancer death worldwide according to the 2009 Korea Central Cancer Registration Annual Report Excellent survival rate 50-70 5-year survival rate can be obtained when surgery is performed including liver transplantation but most 70-80 patients with liver cancer are difficult to get surgery due to liver disease associated with cirrhosis In addition due to the multi-centric nature of liver cancer in patients with cirrhosis repeated treatment is required For these reasons various treatments for liver cancer percutaneous arterial embolization percutaneous ethanol injection radiofrequency heat therapy and radiation therapy have been performed

Due to recent advances in radiotherapy technology proton beam therapy PBT is a promising treatment for liver cancer because it maximizes radiation to tumor tissues and reduces radiation doses from surrounding normal tissues due to the distinct physical properties of proton beams Promising therapeutic results and less toxicity have been reported in liver cancer In addition several genes in liver cancer SOCS-1 GSTP APC VEGF PD-EGF HIF-1 NOS b-FGF LINE-1 p27 TOP2A Ets-1 Bcl-xL Osteopontin CD44 etc have been reported to be associated with recurrence and prognosis
Detailed Description: Liver cancer is the fourth most common malignant tumor in Korea and it is the third most common cause of cancer death worldwide according to the 2009 Korea Central Cancer Registration Annual Report Excellent survival rate 50-70 5-year survival rate can be obtained when surgery is performed including liver transplantation but most 70-80 patients with liver cancer are difficult to get surgery due to liver disease associated with cirrhosis In addition due to the multi-centric nature of liver cancer in patients with cirrhosis repeated treatment is required For these reasons various treatments for liver cancer percutaneous arterial embolization percutaneous ethanol injection radiofrequency heat therapy and radiation therapy have been performed

Due to recent advances in radiotherapy technology proton beam therapy PBT is a promising treatment for liver cancer because it maximizes radiation to tumor tissues and reduces radiation doses from surrounding normal tissues due to the distinct physical properties of proton beams Promising therapeutic results and less toxicity have been reported in liver cancer In addition several genes in liver cancer SOCS-1 GSTP APC VEGF PD-EGF HIF-1 NOS b-FGF LINE-1 p27 TOP2A Ets-1 Bcl-xL Osteopontin CD44 etc have been reported to be associated with recurrence and prognosis Therefore in this study the investigator is going to establish a prospective cohort of liver cancer patients treated with proton beam therapy It be used for analyzing local control survival recurrence toxicity proton treatment plan information gene expression information then local control LC overall survival overall survival OS recurrence-free surival RFS and factors that predict treatment-related toxicity

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None