Chemoembolization in Hepatocellular Carcinoma or Neuroendocrine Hepatic Metastases: A Phase II Multi-Center Trial

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progression

Outcome Description:

Time to progression was defined as time from embolization to documented disease progression. Patients without documented progression were censored at the time of the last documented disease evaluation or of the last treatment ended, whichever was more recent.Disease progression was defined as significant increase in size of lesions or appearance of new metastatic lesions. Specifically, 1) >=25% increase in the area of any malignant lesions greater than 2 cm² or in the sum of the products of the individual lesions in a given organ site; 2)>=50% increase in the size of the product of diameters if only one lesion is available for measurement and was less than or equal to 2 cm² in size at the initiation of therapy; 3)>=25% increase in the sum of the liver measurements below the costal margins and xyphoid; 4)Appearance of new malignant lesions

Outcome Time Frame:

Assessed every 3 months for 2 years, then every 6 months for 3 year.

Safety Issue:

No

Principal Investigator

Keith E. Stuart, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067083

NCT ID:

NCT00003907

Start Date:

August 1999

Completion Date:

August 2012

Related Keywords:

• Liver Cancer
• Metastatic Cancer
• localized unresectable adult primary liver cancer
• advanced adult primary liver cancer
• recurrent adult primary liver cancer
• adult primary hepatocellular carcinoma
• liver metastases
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Carcinoma, Hepatocellular