Radiation Dose Escalation Study for Advanced Liver Cancer

The purpose of this clinical study is to determine the maximum tolerated dose (MTD) of 3-dimensional conformal radiation therapy (3-DCRT)/intensity modulated radiation therapy (IMRT) for locally advanced hepatocellular carcinoma (HCC).

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular 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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Pathologically confirmed or clinically diagnosed HCC
Surgically unsectable or medically inoperable diseases, or surgery declined by the patient
Solitary intrahepatic lesion with diameter bigger than 5 cm, without extrahepatic and/or distant metastases
Associated with cirrhosis of Child-Pugh A
Karnofsky performance status (KPS) of ≥ 70
Normal renal function and adequate bone marrow reservation
Tolerate active breathing control (ABC)

Exclusion criteria

Child-Pugh B or C liver cirrhosis score
Previous radiotherapy to the liver
Indistinct tumor boundary in CT/MRI image

Treatment and study plan

3DCRT/IMRT

Radiation

The starting radiation doses were the total tumor doses of 46 Gy in 2 Gy per fractions for arm I . Escalation was achieved by increasing the tumor dose of each cohort in increments of 4.0 Gy. Subsequent cohorts received higher doses up to a chosen maximum of 62 Gy for arm I.

Primary outcomes

Toxicity was graded using the CTCAE 3.0. Dose-limiting toxicity was defined as acute ≥ grade 3 hepatic or gastrointestinal toxicity, or any grade 5 treatment-related adverse event, or late complication of radiation-induced liver disease.

Time frame: 4 months

Secondary outcomes

1,2 and 3 years survival

Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Feb 20, 2009
Registry last updated: Feb 20, 2009

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.

Completed