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Clinical Trials/NCT04466124
NCT04466124
Enrolling By Invitation
Not Applicable

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

National Cancer Center, Korea1 site in 1 country500 target enrollmentSeptember 21, 2018
ConditionsLiver Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Cancer
Sponsor
National Cancer Center, Korea
Enrollment
500
Locations
1
Primary Endpoint
Establish a cohort of liver cancer patients treadted with proton beam therapy.
Status
Enrolling By Invitation
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 21, 2018
End Date
August 31, 2028
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tae Hyun Kim

Principal Investigator

National Cancer Center, Korea

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Disagreed to participate in this study

Outcomes

Primary Outcomes

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

Time Frame: Up to 10 years

The primary outcome is to establish a prospective cohort of liver cancer patients treadted with proton beam therapy. It is for exploration of factors and models that predict local control, recurrence, survival and treatment-related toxicity in liver cancer patients undergoing proton therapy.

Study Sites (1)

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