Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma
South Korea45 participantsStarted 2015-03-05
Plain-language summary
This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy (PBT) for Hepatocellular Carcinoma patients in hepatitis B endemic area.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Hepatocellular Carcinoma diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation
* Inoperable HCC or refusal to surgery
* Recurrent/residual tumor after other local treatments (local ablation therapy, or transarterial chemoemobolization, etc), or unsuitable/refusal to other treatments.
* Patients without evidence of extrahepatic metastasis
* The largest diameter of tumor should be less than 7cm, and the number of tumor ≤2
* The targeted tumors is more than 2cm away from the alimentary tract (i.e., stomach, duodenum, esophagus, small and large bowel)
* No previous treatment to target tumors by other forms of RT
* Liver function of Child-Pugh class A or B7 (Child-Pugh score of ≤7)
* Age of ≥18 years
* Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) score
* Required Entry Laboratory Parameters WBC count ≥ 1,500/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 30,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT \< 5.0× upper limit of normal; no uncontrolle…