Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma

NCT ID: NCT02395523

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-05
• Study Completion Date: 2020-05-18

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Proton Beam Therapy

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: RADIATION

Other Intervention Names

Radiotherapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Tae Hyun Kim

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tae Hyun Kim, Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

NCCCTS-15-042

Identifier Type: -

Identifier Source: org_study_id