Prospective Cohort Study of Liver Cance… | Clinical Trial

Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Center Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liver Cancer Patients Treated With Proton Beam Therapy

Radiation

Proton Beam Therapy

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.

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2028
Study completion: 2028
First posted: Jul 10, 2020
Registry last updated: Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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