Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma

NCT02395523 | Completed

• 1 other identifier: NCCCTS-15-042
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• overall survival

  Up to5 years until study closed

Study Arms (1)

Proton Beam Therapy

EXPERIMENTAL

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

Radiation: Proton Beam Therapy

Interventions

Proton Beam Therapy 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

Also known as: Radiotherapy

Proton Beam Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 411-769, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Proton Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Therapeutics

Study Officials

• Tae Hyun Kim, Ph.D

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 23, 2015
• Study Start: March 5, 2015
• Primary Completion: March 26, 2020
• Study Completion: May 18, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

KR (1)