A Phase II Study Using Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- National Cancer Center, Korea
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- local progression-free survival
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy (PBT) for HCC 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 for each arms will be enrolled.
Investigators
Tae Hyun Kim
Principal investigator
National Cancer Center, Korea
Eligibility Criteria
Inclusion Criteria
- •HCC 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
- •HCC patients who were not prospective suitable or refused for any other treatment, such as surgery or local ablation therapy, or recurrent or residual tumor after other treatments.
- •without evidence of extrahepatic metastasis
- •All target tumors must be encompassable within single irradiation field (15x15 cm maximum)
- •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 2 on the Eastern Cooperative Oncology Group (ECOG) score
- •WBC count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 25,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT \< 5.0× upper limit of normal; no ascites)
- •no serious comorbidities other than liver cirrhosis
Exclusion Criteria
- •evidence of extrahepatic metastasis
- •age \< 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 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
- •multicentric HCCs, except for those with the following two conditions: \*multinodular aggregating HCC that could be encompassed by single clinical target volume and within single irradiation field (15x15 cm maximum) \*lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy.
Outcomes
Primary Outcomes
local progression-free survival
Time Frame: Up to 1 year
To evaluate the local progression-free survival (LPFS) in HCC patients treated with hypofractionated proton beam radiotherapy.
Secondary Outcomes
- overall survival(Up to 2years until study closed)