hepatocellular carcinoma
Conditions
Interventions
Once daily RT sessions with 2 Gy, five days a week (on weekdays), will be
performed.
Phase I: Dose finding according to the following escalation table:
Dose level Radiotherapy dose (1 x 2 Gy session
Sponsors
SAKK - Swiss Group for Clinical Cancer Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.patient must give informed consent before registration 2.confirmed diagnosis of HCC 3.stage: cT2-4, cN0-1, M0 or unresectable cT1,cN0-1,M0 4.cirrhosis Child-Pugh class A or B 5.measurable disease 6.residual liver volume: >= 800 ml or >= 40% of total liver volume 7.WHO 0-2 8.adequate hematological volumes 9.adequate hepatic functions 10.adequate coagulation parameter 11.adequate renal function 12.age >= 18 13.ability to tolerate proton-pump inhibitors or H2 antagonists during RT 14.women:not pregnant and adequate contraception must be used; men: agree not to father a child during/ within 4 months after trial 15. compliance and geographic proximity to allow proper staging and follow-up 16. phase I only:adequate pancreatic function
Exclusion criteria
Exclusion criteria: 1.previous malignancy within 5 years 2.previous RT to the abdomen or caudal chest 3.TACE, RFA or RT within 8 weeks before registration 4. concurrent treatment with other experimental drugs or other anti-cancer therapy 5.operable disease (curative intent) or planned liver transplantation 6.nutritional intake 15% 8.presence of clinical ascites 9.presence of encephalopathy 10.recent myocard infarction 11.esophageal varices >or = gr 3 12.syptoms of colitis, enteritis, esophagitis, fistula, gastristis, ileus, necrosis, perforation, stricture or ulcer 13.severe anorexia, constipation, dehydration, diarrhea or vomiting 14.any serious underlyuing condition which could impair teh ability of the patient to participate in the trial 15.concommitant treatment with steroids or NSAIDs durinng RT 16.psychiatric disorder precluding understanding of information on trial related topics or giving informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint of phase I • Dose limiting toxicity (DLT) of RT Primary endpoint of phase II • Best objective response of target liver lesions according to RECIST | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints of phase I • Best objective response of target liver lesions according to RECIST • Adverse events (AEs) Secondary endpoints of phase II • Volumetric response of target liver lesions at 5 months • Time to progression of target liver lesions • Duration of response of target liver lesions • Stable disease of target liver lesions • Time to liver event • Progression-free survival (PFS) • Overall survival (OS) • Compensatory liver tissue hypertrophy • Child-Pugh Score • Adverse events (AEs) • Serum alpha fetoprotein (AFP) level | — |
Countries
Netherlands
Outcome results
None listed