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Radiation Dose Escalation Study for Advanced Liver Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00848094
First Posted: February 20, 2009
Last Update Posted: February 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fudan University
  Purpose
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).

Condition Intervention Phase
Hepatocellular Carcinoma Radiation: 3DCRT/IMRT Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma

Further study details as provided by Fudan University:

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. [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • 1,2 and 3 years survival [ Time Frame: 4 years ]

Enrollment: 40
Study Start Date: April 2005
Study Completion Date: May 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
arm 2
Arm II: tumor diameter no less than 10 cm.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848094


Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Guoliang Jiang, M.D. Fudan University
  More Information

Responsible Party: Guoliang Jiang, Fudan University Cancer Hospital
ClinicalTrials.gov Identifier: NCT00848094     History of Changes
Other Study ID Numbers: LCR-003
First Submitted: February 19, 2009
First Posted: February 20, 2009
Last Update Posted: February 20, 2009
Last Verified: February 2009

Keywords provided by Fudan University:
hepatocellular carcinoma
radiation therapy
3-dimensional conformal radiation therapy (3-DCRT)
intensity modulated radiation therapy (IMRT)
active breathing control

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases