Tokyo, Sept. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062868) titled 'Clinical trial of 4-fraction proton beam therapy for peripheral hepatocellular carcinoma 4 cm or lager in diameter' on Sept. 14.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Southern TOHOKU Proton Therapy Center
Condition:
Condition - Peripheral hepatocellular carcinoma 4 cm or lager in diameter
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the efficacy and safety of a four-fraction proton beam therapy regimen for hepatocellular carcinoma measuring 4 cm or larger that meets the eligibility criteria.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Four-fraction proton beam therapy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - (1) Patients with a diagnosis of hepatocellular carcinoma confirmed histologically or via MRI
(2) Patients with a localized liver tumor of 4 cm or larger eligible for insurance coverage
(3) Patients with Child-Pugh class A or B liver function
(4) Performance status (PS) (ECOG) 0-2
(5) Patients aged 20 years or older
(6) Patients capable of maintaining the required body position during irradiation and for whom proton beam therapy is technically feasible
(7) Patients who have received an explanation using the designated document and have provided written consent
Key exclusion criteria - Cases meeting any of the following criteria will be excluded:
(1) Tumor located within 2 cm of the gastrointestinal tract or hepatic hilum
(2) History of prior radiotherapy to the planned treatment area
(3) Uncontrolled ascites
(4) Active, refractory infection
(5) Serious complications
(6) Active multiple primary cancers Note: Prostate cancer is excluded if deemed cured by local treatment.
(7) Otherwise judged by the study physician(s) as unsuitable for the safe conduct of this study
Target Size - 35
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 09 Month 09 Day
Date of IRB - 2026 Year 09 Month 09 Day
Anticipated trial start date - 2026 Year 09 Month 10 Day
Last follow-up date - 2031 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071967
Disclaimer: Curated by HT Syndication.
