Radiation Dose Escalation Study for Advanced Liver Cancer
NCT ID: NCT00848094
Last Updated: 2009-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2005-04-30
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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arm 1
Arm I: tumor diameter more than 5 cm and less than 10 cm.
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.
arm 2
Arm II: tumor diameter no less than 10 cm.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous radiotherapy to the liver
* Indistinct tumor boundary in CT/MRI image
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Fudan University Cancer Hospital
Principal Investigators
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Guoliang Jiang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Other Identifiers
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LCR-003
Identifier Type: -
Identifier Source: org_study_id
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