Spots Global Cancer Trial Database for Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver
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Trial Identification
Brief Title: Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver
Official Title: Chemoembolization in Hepatocellular Carcinoma or Neuroendocrine Hepatic Metastases: A Phase II Multi-Center Trial
Study ID: NCT00003907
Study Description
Brief Summary: RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. PURPOSE: Phase II trial to study the effectiveness of chemoembolization in treating patients who have primary liver cancer or metastases to the liver that cannot be surgically removed.
Detailed Description: OBJECTIVES: * Evaluate time to progression of disease in patients with unresectable hepatocellular carcinoma or neuroendocrine hepatic metastases undergoing chemoembolization. * Evaluate tumor response achievable with chemoembolization in this patient population. * Evaluate the toxicities of this treatment in these patients. * Evaluate survival of these patients following this treatment. * Evaluate extrahepatic patterns of failure following chemoembolization, to determine whether intrahepatic progression may be forestalled and survival affected in these patients. * Validate a consistent method of performing chemoembolization in a multicenter setting. OUTLINE: Patients are stratified according to disease (hepatocellular carcinoma vs neuroendocrine hepatic metastases). Patients undergo placement of a visceral arterial catheter. Patients receive doxorubicin, mitomycin, and cisplatin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only. Immediately following delivery of the chemoemulsion, particulate embolization is performed. The opposite lobe, if involved, is treated within 3-5 weeks of treatment of the initial lobe. In the absence of unacceptable toxicity, each involved lobe is treated separately a second time, in the same sequence, beginning 8 weeks after the last lobular chemoembolization. After completion of all protocol therapy, retreatment on study of either lobe is allowed for regrowth, recurrence, or new disease, provided at least 3 months have elapsed since the initial treatment of that lobe. Patients are followed for 5 years. PROJECTED ACCRUAL: A total of 19-42 patients will be accrued for this study within 1 year.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Front Range Cancer Specialists, Fort Collins, Colorado, United States
Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Hematology and Oncology Associates, Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, United States
Mercy Hospital and Medical Center, Chicago, Illinois, United States
Swedish Covenant Hospital, Chicago, Illinois, United States
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois, United States
Midwest Center for Hematology/Oncology, Joliet, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville, Libertyville, Illinois, United States
Hematology Oncology Associates - Skokie, Skokie, Illinois, United States
Hematology/Oncology of the North Shore at Gross Point Medical Center, Skokie, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States
Mercy Capitol Hospital, Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines, West Des Moines, Iowa, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital, Morristown, New Jersey, United States
Somerset Medical Center, Somerville, New Jersey, United States
Overlook Hospital, Summit, New Jersey, United States
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
St. Rita's Medical Center, Lima, Ohio, United States
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States
Contact Details
Name: Keith E. Stuart, MD
Affiliation: Beth Israel Deaconess Medical Center
Role: STUDY_CHAIR
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