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Phase II study of image-guided proton therapy for solitary primary hepatocellular carcinoma with indication for standard treatment

Phase II study of image-guided proton therapy for solitary primary hepatocellular carcinoma with indication for standard treatment - Phase II study of image-guided proton therapy for solitary primary hepatocellular carcinoma with indication for standard treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000036743
Enrollment
45
Registered
2019-05-20
Start date
2013-06-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

solitary primary hepatocellular carcinoma

Interventions

Sponsors

Nagoya City West Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) histologically-confirmed or image-diagnosed solitary primary HCC staged as T1N0M0 (UICC TNM 7th ed.) 2) no history of previous HCC 3) patient refusal of surgery or radiofrequency ablation 4) no previous radiotherapy around the lesion 5) age: 20-80 years old 6) ECOG-PS: 0-1 7) Child-Pugh classification A5, 6 or B7 8) dose constraints of the organs at risk achievable 9) tumor diameter < 12 cm 10) written informed consent

Exclusion criteria

Exclusion criteria: 1)pregnancy or lactation 2)severe psychological disorders 3)active and uncontrolled infection 4)Other cancers within 5 years 5)continuous systemic administration (oral or intravenous) of steroids 6)esophageal varix at high risk of bleeding (F3, Rc ++ or higher) 7)portal vein tumor thrombosis 8)cases in which the doctor is judged inappropriate for medical, psychological or other reasons other than the above

Design outcomes

Primary

MeasureTime frame
2-year overall survival

Secondary

MeasureTime frame
local control rate, progression free survival,response rate,incidence of grade 3 or higher adverse events,change of quality of life (QOL)

Countries

Japan

Contacts

Public ContactHiromitsu Iwata

Nagoya City West Medical Center,Nagoya Proton Therapy Center Radiation oncology

h-iwa-ncu@nifty.com052-991-8577

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026