A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer

Completed · Phase 2

Conditions studied: Liver Cancer, Hepatocellular Cancer

In brief

This is a Phase II trial to characterize the safety and efficacy of individualized stereotactic body radiation therapy (SRBT) for patients who have had previous liver treatment or who have primary hepatocellular carcinoma (HCC).

Key facts

Study ID

NCT01522937

Run by

University of Michigan Rogel Cancer Center

People needed

94

Starts

2009-10-01

Expected to finish

2015-11-01

Last updated by the study team

2017-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• over age 18
• life expectancy of at least 12 weeks
• Zubrod performance status of ≤2.
• biopsy proven hepatocellular carcinoma (HCC)
• liver metastases
• a discrete hepatic tumor(s) as defined by the Barcelona46 criteria - for cirrhotic patients, (1) 2 imaging studies showing hypervascular tumor > 2cm, or (2) single imaging study showing hypervascular tumor > 2cm with AFP ≥ 400 ng/mL
• a discrete hypervascular tumor present on two consecutive imaging studies (CT or MRI) with documented growth of > 1cm in diameter
• adequate organ function
• women and men not interested in pregnancy
• must be recovered from the effects of any prior surgery, radiation therapy, chemotherapy and the effects of Radiofrequency Ablation (RFA) or Transcatheter Arterial Chemo Embolization (TACE)
• minimum of 6 weeks following their last surgical procedure, radiation and chemotherapy.

You may not qualify if…

• cannot be eligible for a curative liver resection
• uncontrolled ascites clinically evident on physical exam
• known allergy to IC-Green
• known allergy to intravenous iodinated contrast agents
• patients with poor venous access
• patients with metastatic cancer with normal liver function who have not undergone previous liver directed therapy and a single tumor < 6 cm in size.

Where it is running

• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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