Primary liver cancer
Conditions
Interventions
Sponsors
Department of Radiation Medicine, Hokkaido University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically proven or Radiologically diagnosed hepatocellular carcinoma (HCC) 2) WBC count >= 2,000/mm3; hemoglobin level >= 7.5 g/dL; platelet count >= 25,000/mm3; total bilirubin <= 3.0 mg/dL; SGOT (AST) and SGPT (ALT) < 5.0 x upper limit of normal 3) Unfeasible, difficult or refusal to undergo surgery or radiofrequency ablation 4) Visible target on CT and/or MRI 5) ECOG-PS 0-2 6) Age 20-yrs old or over at the time of consent form is obtained 7) Explained well and consent to this study
Exclusion criteria
Exclusion criteria: 1) With active infections in the irradiated sites 2) With active other cancers 3) With severe uncontrolled diabetes 4) With severe renal failure which needed dialysis 5) With severe heart disease, or some serious complications, i.e., SLE, Scleroderma, interstitial pneumonia 6) With an inflammatory bowel syndrome, i.e., Crohn's disease, ulcerative colitis 7) Previous abdominal irradiation 8) Previous treatment for the tumor within 30 days 9) With ascites of grade 2 or higher (CTCAE ver4.03) 10) Hepatic function characterized by a Child-Pugh score 10 or over 11) Extrahepatic metastasis 12) Multicentric HCCs, except for those with the following two conditions: (1) multinodular aggregating HCC that could be encompassed by single clinical target volume; (2) lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy. 13) Maximum tumor diameter on CT and/or MRI over 10 cm 14) Tumor within 2 cm of the gastrointestinal tract 15) Total occlusion of the main trunk and/or major branches of the portal vein (the main left and right portal veins) by tumor thrombus. 16) With implantable cardioverter defibrillator or permanent pacemaker 17) Pregnancy 18) Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis 19) Cannot be held rest for about 30 minutes 20) Weight over 135 kg 21) Cannot be implanted Au marker in the lung 22) Allergic to radiation 23) Unsuitable for enrollment judged by principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of proton-induced hepatic insufficiency within 6 months after real-time tumor-tracking proton beam therapy. Development of hepatic insufficiency presented with anicteric ascites and/or asterixis within 6 months after completion of proton beam therapy in the absence of disease progression was defined as proton-induced hepatic insufficiency. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year overall survival, local control, progression free survival, recurrence pattern, incidence of adverse effect, incidence of dropout of internal fiducial markers during treatment period | — |
Countries
Japan
Contacts
Public ContactNorio Katoh
Hokkaido University Graduate School of Medicine Department of Radiation Medicine
Outcome results
None listed