Radiation Dose Escalation Study for Advanced Liver Cancer
Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma
1 other identifier
interventional
40
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hepatocellular-carcinoma
Started Apr 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 19, 2009
CompletedFirst Posted
Study publicly available on registry
February 20, 2009
CompletedFebruary 20, 2009
February 1, 2009
2.8 years
February 19, 2009
February 19, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
1,2 and 3 years survival
4 years
Study Arms (2)
arm 1
OTHERArm I: tumor diameter more than 5 cm and less than 10 cm.
arm 2
OTHERArm II: tumor diameter no less than 10 cm.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Child-Pugh B or C liver cirrhosis score
- Previous radiotherapy to the liver
- Indistinct tumor boundary in CT/MRI image
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guoliang Jiang, M.D.
Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 19, 2009
First Posted
February 20, 2009
Study Start
April 1, 2005
Primary Completion
January 1, 2008
Study Completion
May 1, 2008
Last Updated
February 20, 2009
Record last verified: 2009-02