Radiation Dose Escalation Study for Advanced Liver Cancer

February 19, 2009 updated by: Fudan University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: arm 1
Arm I: tumor diameter more than 5 cm and less than 10 cm.
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.
Radiation: 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.
Other: arm 2
Arm II: tumor diameter no less than 10 cm.
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.
Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
1,2 and 3 years survival
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Guoliang Jiang, M.D., Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

February 19, 2009

First Submitted That Met QC Criteria

February 19, 2009

First Posted (Estimate)

February 20, 2009

Study Record Updates

Last Update Posted (Estimate)

February 20, 2009

Last Update Submitted That Met QC Criteria

February 19, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCR-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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