Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643824
• Other study ID #: NCCCTS-12-622
• Status: Completed
• Phase: N/A
• Start date: June 7, 2012
• Est. completion date: April 30, 2017

Study information

• Verified date: August 2018
• 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 HCC 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 for each arms will be enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• written informed consent

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• Proton Beam Therapy
- Prescription dose to PTV as according to the following dose escalation schema: Arml 1: 60 GyE /10 fx, 6GyE fraction dose, 5 days/week, for HCC free from the alimentary tract (i.e., stomach, duodenum, esophagus, small and large bowel) (more than 2cm from clinical target volume), TLV30 <40%, and/or RLV30 <30%) Arm 2: 50 GyE /10 fx, 5GyE fraction dose, 5 days/week, for HCC close to the alimentary tract (less than 2cm from clinical target volume) but not contact with the alimentary tract, TLV30<50% and RLV30<40% Arm 3: 35 GyE /10 fx, 4GyE fraction dose, 5 days/week, for HCC contact to the alimentary tract (contact with clinical target volume), TLV30<60%, and/or RLV30<50% - 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	To evaluate the local progression-free survival (LPFS) in HCC patients treated with hypofractionated proton beam radiotherapy.	Up to 1 year
Secondary	overall survival	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	Up to 2years until study closed