Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

A Phase II Study Using Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395523
• Other study ID #: NCCCTS-15-042
• Status: Completed
• Phase: N/A
• Start date: March 5, 2015
• Est. completion date: May 18, 2020

Study information

• Verified date: July 2020
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 18, 2020
• Est. primary completion date: March 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• Proton 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

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Korea	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local progression - free survival	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)	Up to 5 year
Secondary	overall survival	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)	Up to5 years until study closed