Radiation Dose Escalation Study for Advanced Liver Cancer

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848094
• Other study ID #: LCR-003
• Status: Completed
• Phase: Phase 1
• First received: February 19, 2009
• Last updated: February 19, 2009
• Start date: April 2005
• Est. completion date: May 2008

Study information

• Verified date: February 2009
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• 3DCRT/IMRT
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.
• 3DCRT/IMRT
The starting radiation doses were the total tumor doses of 40 Gy in 2 Gy per fractions for arm II. 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 52 Gy for arm II.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		4 months	Yes
Secondary	1,2 and 3 years survival		4 years	No