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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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1,2 and 3 years survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848094

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

No publications provided

Responsible Party: Guoliang Jiang, Fudan University Cancer Hospital
ClinicalTrials.gov Identifier: NCT00848094     History of Changes
Other Study ID Numbers: LCR-003
Study First Received: February 19, 2009
Last Updated: February 19, 2009
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013