CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 77 enrolled
Drug / intervention
Stereotactic Body Radiationradiation
Likely dose
Hypofractionated stereotactic body radiation therapy: 3 fractions (Child-Pugh A) or 5 fractions (Child-Pugh B)AI-extracted
Key inclusion· 6
  • ✓Not a candidate for standard therapy to target area (upper abdomen) per Surgery and/or Liver Transplant Team evaluation
  • ✓Total bilirubin <3 mg/dL and albumin >2.5 g/dL
  • ✓Normal PT/PTT unless on anticoagulants
  • ✓Liver enzymes <3 times upper limit of normal
Key exclusion· 5
  • ✕History of systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, or scleroderma
  • ✕Chemotherapy within 14 days before radiotherapy
  • ✕Chemotherapy planned within 2 weeks after radiotherapy
  • ✕Active liver infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00243841
NCT00243841N/ACompleted
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Multi-institution Phase I/II Dose Escalation Study of Hypofractionated Stereotactic Body Radiation Therapy for Primary Hepatocellular Carcinoma

Indiana University·interventional·Posted Oct 25, 2005·Updated Dec 13, 2018

In Brief

A clinical study evaluating Stereotactic Body Radiation for Carcinoma, Hepatocellular. Completed, enrolled 77 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the maximum tolerated dose of limited fractions of large dose radiation in an effort to achieve a biologically potent cancer therapy in selected patients with primary hepatocellular carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesUnited States
CollaboratorsUniversity of Colorado, Denver

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 25, 2005
Enrollment StartMay 1, 2004
Primary CompletionDec 31, 2016
TodayJul 2, 2026
Enrollment to primary: 12.7 yearsPosted 20.7 years ago

Interventions

Stereotactic Body Radiationradiation

Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.