Radiation Dose Escalation Study for Advanced Liver Cancer

This study has been completed.
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00848094
First received: February 19, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 19, 2009
February 19, 2009
April 2005
January 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
1,2 and 3 years survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Radiation Dose Escalation Study for Advanced Liver Cancer
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).

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • 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.
  • arm 1
    Arm I: tumor diameter more than 5 cm and less than 10 cm.
    Intervention: Radiation: 3DCRT/IMRT
  • arm 2
    Arm II: tumor diameter no less than 10 cm.
    Intervention: Radiation: 3DCRT/IMRT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00848094
LCR-003
Yes
Guoliang Jiang, Fudan University Cancer Hospital
Fudan University
Not Provided
Principal Investigator: Guoliang Jiang, M.D. Fudan University
Fudan University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP