Prospective Cohort Study of Liver Cancer Patients Treated With Proton Beam Therapy

• Conditions: Liver Cancer

• Registration Number: NCT04466124
• Lead Sponsor: National Cancer Center, Korea

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 Timeline

• Study Start: 2018-09-21
• Status Verified: 2020-07
• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-09
• Last Update Submitted: 2020-07-09
• Study First Posted: 2020-07-10
• Last Update Posted: 2020-07-13
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

National Cancer Center Korea; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of