Feasibility of High Dose PROton Therapy On Unresectable Primary Carcinoma Of Liver: Prospective Phase II Trial

Samsung Medical Center

Status and phase

Unknown

Phase 2

Conditions

Proton Therapy

Liver Neoplasm

Treatments

Radiation: Proton arm

Study type

Interventional

Funder types

Other

Identifiers

NCT02632864

2015-08-004

Details and patient eligibility

About

The standard treatment of unresectable hepatocellular carcinoma (HCC) is transarterial chemoembolization (TACE) or sorafenib. Though the TACE and the agent showed survival benefit in several randomized phase III trials, the benefit was modest.

Recently, radiotherapy (RT), especially conformal and higher dose with the advancement of RT techniques, showed favorable response rate with acceptable local control rate. Based on those promising results, RT was actively applied in HCC who are not indicated with surgery and/or radiofrequency ablation.

Many researchers reported that there is a relationship between RT dose and tumor response rate. RT dose, however, is frequently limited because the complications (like radiation induced liver disease (RILD), radiation induced gastro-duodenal toxicity, etc.) are also closely related with higher exposed RT dose.

Proton beam has characteristic depth-dose distribution contrast to photon, the "Bragg peak". The advantage of this dose distribution could be more highlighted in HCC management, because of the weakness and maintenance importance of liver function itself in HCC patients. In fact, the superior results of proton beam therapy in HCC were constantly reported in several groups as prospectively as well as retrospectively.

In this background, the investigators planned the present study to evaluate the efficacy and safety of proton beam therapy in HCC patients who are not indicated with surgery and/or radiofrequency ablation (RFA).

Enrollment

66 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Hepatocellular carcinoma (HCC) patients (Pathologically proven or HCC diagnosed based on American Association for the Study of Liver Diseases (AASLD) guideline)
Not indicated with surgical resection and/or RFA
Discussion in tumor board including gastroenterologist, radiologist, radiation oncologist
Eastern Cooperative Oncology Group performance status 0 to 2 within 1 week before participate
Adequate bone marrow function (absolute neutrophil count ≥ 1.0 x 109/l, platelet ≥ 30 x 109/l, hemoglobin ≥ 8 g/dl)
Adequate liver/renal function within 1 week before participate
Total bilirubin <3.0 mg/dL, Prothrombin time/International normalized ratio <1.7, Albumin≥2.8g/dL, Aspartate aminotransferase/alanine aminotransferase<6 times of upper normal limit Serum creatinine < 1.5 x upper normal limit, glomerular filtration rate > 50 ml/min
Informed consent
If viable tumor is single, 1 cm to 10 cm
Less than 3 nodules
Child-Pugh class A, B, or early C (score ≤ 10)
Women of childbearing potential and male participants must agree to practice adequate contraception while on study and for at least 6 months following the last dose of RT

Exclusion criteria

Uncontrolled hepatic encephalopathy
Previous history of upper abdominal radiotherapy
Status of pregnancy or breast feeding
Less than 12 weeks of expected survival
Uncontrolled ascites
Combined with disease known as radiosensitive disorder (connective tissue disorder, Ataxia-telangiectasia)
Hard to maintain stable respiration less than 5 minutes related with respiratory disease
Combined with uncontrolled severe acute disease other than liver