Phase I Study Evaluating the Treatment of Patients With Hepatocellular Carcinoma (HCC) With Carbon Ion Radiotherapy
Inclusion Criteria:
- histologically confirmed HCC or diagnosis of HCC according to AASLD-guidelines
- macroscopic tumor
- liver-confined disease without extrahepatic disease as diagnosed by CT, MRT,
ultrasound and bone scan
- minimal distance of tumor edge to the intestines of 1cm
- age ≥ 18 years of age
- Karnofsky Performance Score ³60
- For women with childbearing potential, (and men) adequate contraception.
- Ability of subject to understand character and individual consequences of the
clinical trial
- Written informed consent (must be available before enrolment in the trial)
Exclusion Criteria:
- refusal of the patients to take part in the study
- previous radiotherapy of the hepatobiliary system
- margin of < 1cm between tumor edge and intestines
- Patients who have not yet recovered from acute toxicities of prior therapies
- Known carcinoma < 2 years ago (excluding Carcinoma in situ of the cervix, basal cell
carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment
interfering with study therapy
- Pregnant or lactating women
- Participation in another clinical study or observation period of competing trials,
respectively