Dose Escalation Study Using Proton Beam Radiotherapy for Hepatocellular Carcinoma

The radical treatment for Hepatocellular carcinoma (HCC) is surgery. However, it is only for 10 to 20% of all patients and 10 to 30% of them have relapsed every year after surgery. For an inoperable case, we can consider Liver transplantation. But there is not enough organ donor and it is very expensive. In that case, various treatment modalities for HCC (i.e., transcatheter arterial embolization [TAE] and percutaneous ethanol injection [PEI], radiofrequency ablation etc.) have become clinically available. In addition, after these treatment, radiation therapy can be conducted as a combined treatment. If it is difficult, radiation therapy can be conducted alone. In this case, radiation therapy can use fractionated stereotactic radiation therapy [FSRT] or 3D simulation to minimize the exposure to normal tissues. In recent years, Proton therapy is a new radiation therapy which remaining energy is released when they reach the tumor, delivering the most effective dose of radiation. The purpose of this trial is to improve the therapeutic effects by using proton therapy.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 400 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms
(ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 400 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 (12x12 cm maximum)
No previous treatment to target tumors by other forms of RT
Digestive tract not in contact with clinical target volume
Liver function of Child-Pugh class A or B
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

Exclusion criteria

Evidence of extrahepatic metastasis
Age < 18 years
Liver function of Child-Pugh class C
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
Diffusely infiltrating tumor which is difficult to define the gross tumor volume accurately
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 irradiation field (15x15 cm maximum)
(ii) lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy
Digestive tract in contact with clinical target volume
Pregnant or breast feeding status
Previous history uncontrolled other malignancies within 2 years

Treatment and study plan

respiratory gated proton beam radiotherapy

Radiation

Prescription dose to PTV as according to the following dose escalation schema: Dose level 1: 60 GyE /20 fx, 3GyE fraction dose, 5 days/week. Dose level 2: 66 GyE /22 fx, 3GyE fraction dose, 5 days/week. Dose level 3: 72 GyE /24 fx, 3GyE fraction dose, 5 days/week.

Primary outcomes

all cause mortality

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

A Phase I Dose Escalation Study Using Proton Beam Radiotherapy for Hepatocellular Carcinoma

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Apr 21, 2008
Registry last updated: Apr 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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