Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma
- Registration Number
- NCT01643824
- Lead Sponsor
- National Cancer Center, Korea
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- 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
- written informed consent
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method local progression-free survival Up to 1 year To evaluate the local progression-free survival (LPFS) in HCC patients treated with hypofractionated proton beam radiotherapy.
- Secondary Outcome Measures
Name Time Method overall survival Up to 2years until study closed * To evaluate compliance of proton beam radiotherapy for HCC by analyzing acute and late treatment-related toxicity, such as radiation-induced hepatic toxicity and gastrointestinal tract toxicity
* To evaluate the impact of hypofractionated proton beam radiotherapy for HCC by analyzing the tumor response rate, local disease-free survival (DFS) and overall survival (OS) rate
Trial Locations
- Locations (1)
National Cancer Center, Korea
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
National Cancer Center, Korea🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of