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Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00241020
First received: October 14, 2005
Last updated: November 15, 2012
Last verified: November 2012
History of Changes

October 14, 2005
November 15, 2012
June 2002
March 2008   (final data collection date for primary outcome measure)
Overall Survival
Not Provided
Complete list of historical versions of study NCT00241020 on ClinicalTrials.gov Archive Site
  • Objective response
  • Survival without progression
  • Digestive bleeding
  • Renal insufficiency
  • Quality of life
  • · Safety
Not Provided
Not Provided
Not Provided
 
Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma
Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is one of the most common malignant disease worldwide with an increasing incidence in industrialized countries. For patients with advanced HCC no efficient treatment is currently available. The objective of this study is to assess the efficacy and safety of octreotide in patients with advanced hepatocellular carcinoma.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Advanced Hepatocellular Carcinoma
Drug: Octreotide
Experimental: Octreotide
Intervention: Drug: Octreotide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • > 18 years
  • HCC diagnosis :
  • histologically or cytologically proven HCC
  • or association of the three following criteria:
  • cirrhosis
  • typical measurable mass (> 3cm, by 2 methods)
  • serum alpha-foetoprotein (AFP) ≥500 µg/L
  • Cancer Liver Italian Program (CLIP) score : 0 to 3
  • Not eligible for specific treatment (surgery, percutaneous ablation or chemo-embolization)

Exclusion Criteria:

  • Glycemia > 2.5 g/L or hypoglycemia
  • Extra hepatic life-threatening disease
  • Serum creatinin> 120 µmol/L
  • Prothrombin time < 50 %
  • Platelet count < 50.000 /µL
  • Symptomatic cholelithiasis
  • Non-measurable tumor
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00241020
CSMS995BFR04
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP