A Retrospective Review of Malignant Liver Tumors

Liver Cancer Clinical Trial

Official title:

A Retrospective Review of Malignant Liver Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728650
• Other study ID #: TAB11119
• Status: Completed
• Phase: N/A
• First received: August 1, 2008
• Last updated: February 6, 2012
• Start date: October 2003
• Est. completion date: June 2011

Study information

• Verified date: February 2012
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study will review the treatment and outcomes of patients having primary and metastatic hepatic malignancies. Patients treated with surgical resection, percutaneous radiofrequency ablation (RFA), and transarterial chemoembolization (TACE) will be compared with patients not receiving these treatments. Tumor recurrence and survival data will be compared to the published literature to determine the efficacy of current treatment strategies in this patient population.

Description:

Subjects will be identified by diagnosis and procedure codes from a university surgical practice and the St. John Medical Center Cancer Registry. Data will be obtained by review of both the clinic and hospital charts. In addition we plan to review and utilize liver tumor treatment and outcomes data from a national database. Treatment decisions, in cases managed by the primary investigator, were made on a clinical basis, often in collaboration with an interventional radiologist. Of the patients managed by the principal investigator, all procedures were undertaken after an informed consent process. Subjects were not exposed to risk beyond that posed by the recommended treatment. All treatments were within the scope of standard medical care. The primary investigator has no knowledge of the treatments chosen for the patients he did not manage. The subject's referring physician may be contacted to obtain follow-up data on the subject. The follow-up data will include: is the patient alive with disease; alive without disease, alive unknown; dead free of disease; dead with disease; dead unknown.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: June 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with primary or metastatic hepatic malignancies

Exclusion Criteria:

• Patients not diagnosed with primary or metastatic hepatic malignancies

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Locations

Country	Name	City	State
United States	The University of Oklahoma College of Medicine, Tulsa - Department of Surgery	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (1)

Curley SA, Izzo F, Delrio P, Ellis LM, Granchi J, Vallone P, Fiore F, Pignata S, Daniele B, Cremona F. Radiofrequency ablation of unresectable primary and metastatic hepatic malignancies: results in 123 patients. Ann Surg. 1999 Jul;230(1):1-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		lifetime	No
Secondary	Efficacy		lifetime	No