Digestive System Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Infections

Rare Diseases

Liver Cirrhosis

Carcinoma

Carcinoma, Hepatocellular

Hepatitis A

Hepatitis

Hepatitis B

Virus Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Herpes Simiae (B Virus)

All enrolled patients will receive 3.5 Gy per fraction (five fractions per week) at the following levels;

Dose escalation by 7 Gy in 2 fractions to maximum of 63 Gy, as follows:

Dose Level I: 3.5 Gy for 12 fractions (42 Gy total) Dose Level II: 3.5 Gy for 14 fractions (49 Gy total) Dose Level III: 3.5 Gy for 16 fractions (56 Gy total) Dose Level VI: 3.5 Gy for 18 fractions (63 Gy total)

3DCRT or IMRT

Jason Chia-Hsien Cheng, Ph.D.

Hepatocellular carcinoma (HCC) is one of the leading malignancies in Taiwan. Surgery and local ablative therapy remain the treatment of choice for curative purpose. Transarterial chemoembolization has been the mainstay of intrahepatic control for patients not being candidates for local modalities of treatment. Sorafenib is recently integrated into the treatment options, mainly for intrahepatic or extrahepatic wide spread disease contraindicated for the other modalities. External radiotherapy (RT) has been selectively used for patients with the localized hepatic tumor(s) refractory to the above treatment options. The data from the retrospective studies were biased by the patient selection and uncontrolled comparison with patients not receiving RT. The obstacles for RT to HCC remain unanswered with heterogeneity in dose of radiation and lower tolerance of liver to RT in viral hepatitis carriers. Such a sublethal dose might be associated with unsatisfactory tumor control, intra-/extra-hepatic metastasis, and radiation-induced liver disease in a significant proportion of HCC patients.

The purposes of this phase I study are primarily to determine the maximally tolerated dose of RT, and secondarily to evaluate the tumor control, to assess patterns of failure and survival, to analyze the characteristics of radiation-induced liver disease, as well as to collect blood samples for translational research. HCC patients who are hepatitis B virus carriers and graded as Child-Pugh A cirrhosis are enrolled. This dose escalation trial is conducted with the 7-Gy increase in 2 fractions (3.5 Gy per fraction) for a total of four levels, from 42 Gy up to 63 Gy. Conformal RT with three-dimensional design, intensity modulated RT, or volumetric modulated arc therapy is used with the defined dose-volume threshold for normal liver and the other structures. Five patients are treated for each dose level, with dose limiting toxicity in less than 2 patients judged to be acceptable. A minimum of 15 patients are required for the starting dose level of 49 Gy if the treated tumor diameter is less than 10 cm. Imaging modalities are used for estimating treatment response and detecting metastasis. Serum analyses are done for evaluating hepatic function, viral load, hematological toxicity, and translational research for angiogenic and inflammatory studies.

A Dose Escalation Trial of Radiation Therapy (RT) for Hepatocellular Carcinoma (HCC)

A Phase I Dose Escalation Trial of Conformal Hypofractionated Radiation Therapy for Patients With Hepatitis B Virus-Related Child A Cirrhosis and Hepatocellular Carcinoma

National Taiwan University Hospital

Jason Chia-Hsien Cheng

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Dose Escalation Trial of Radiation Therapy (RT) for Hepatocellular Carcinoma (HCC)	NCT00960167	Hepatocellular ...	3DCRT or IMRT	18 Years - 70 Years	National Taiwan University Hospital
A Dose Escalation Trial of Radiation Therapy (RT) for Hepatocellular Carcinoma (HCC)	NCT00960167	Hepatocellular ...	3DCRT or IMRT	18 Years - 70 Years	National Taiwan University Hospital

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