Hepatocellular Carcinoma
Conditions
Brief 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.
Detailed description
The primary endpoint is local progression free survival. The trial is a single arm phase II trial with the historical arm. The expected 3-year local progression free survival for patient with HCC patients treated with proton beam therapy would be 80%. With a power of 80% and a type I error level of 10%, evaluable 40 patients are required to reject that the null hypothesis that true 3-year local progression free survival rate is ≤65%. Considering the 10% unevaluable patients due to loss of follow up, a total 45 eligible patients will be enrolled.
Interventions
RADIATIONProton Beam Therapy
Definition of target volume: * Gross tumor volume (GTV) = gross tumor defined using a treatment planning CT scan * Clinical target volume (CTV) = GTV + internal target volume * Planning target volume (PTV) = CTV + 5 - 7 mm of lateral, craniocaudal, and anteroposterior margins. Radiation dose and planning * Prescription dose to PTV: 70 GyE /10 fx, 7GyE fraction dose, 5 days/week * Dose prescription : 95% isodose volume of prescribed dose encompassed PTV
Sponsors
National Cancer Center, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 uncontrolled ascites * No serious comorbidities other than liver cirrhosis * Signed informed consent form prior to study entry
Exclusion criteria
* There is evidence of extrahepatic metastasis. * Age of \<18 years * Liver function of Child-Pugh class B8-9 and C (Child-Pugh score of \>7) * Previous history of other forms of RT adjacent to target tumors * Poor performance status of 2 to 4 on the Eastern Cooperative Oncology Group (ECOG) score * Multicentric HCCs, except for those with the following two conditions: (i) multinodular aggregating HCC that could be encompassed by single clinical target volume and within single clinical target volume; (ii) lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy. * Pregnant or breast feeding status * Previous history uncontrolled other malignancies within 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| local progression - free survival | Up to 5 year | During PBT, patients were assessed weekly and after comletion of PBT at the 1st month, every 3months for the first 2years, every 6 months up to 5years. the tumor responses were assessed according to the modified response evaluation criteria in solid tumors criteria by comparing pre- and posst-PBT CT/MRI scans, and the severity of adverse deffects was graded using the common terminology criteria for adverse events(ver 4.0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | Up to5 years until study closed | During PBT, patients were assessed weekly and after com;letion of PBT at the 1st month, every 3months for the first 2years, every 6 months up to 5years. the tumor responses were assessed according to the modified response evaluation criteria in solid tumors criteria by comparing pre- and posst-PBT CT/MRI scans, and the severity of adverse deffects was graded using the common terminology criteria for adverse events(ver 4.0) |
Countries
South Korea
Outcome results
None listed