Back to resultsRadiation Dose Escalation Study for Advanced Liver Cancer
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
3DCRT/IMRT
3DCRT/IMRT
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, radiation therapy, 3-dimensional conformal radiation therapy (3-DCRT), intensity modulated radiation therapy (IMRT), active breathing control
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
arm 1
arm 2
Arm Description
Arm I: tumor diameter more than 5 cm and less than 10 cm.
Arm II: tumor diameter no less than 10 cm.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
1,2 and 3 years survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00848094
Brief Title
Radiation Dose Escalation Study for Advanced Liver Cancer
Official Title
Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, radiation therapy, 3-dimensional conformal radiation therapy (3-DCRT), intensity modulated radiation therapy (IMRT), active breathing control
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
arm 1
Arm Type
Other
Arm Description
Arm I: tumor diameter more than 5 cm and less than 10 cm.
Arm Title
arm 2
Arm Type
Other
Arm Description
Arm II: tumor diameter no less than 10 cm.
Intervention Type
Radiation
Intervention Name(s)
3DCRT/IMRT
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
3DCRT/IMRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
1,2 and 3 years survival
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoliang Jiang, M.D.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Radiation Dose Escalation Study for Advanced Liver Cancer
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