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Trial registered on ANZCTR


Registration number
ACTRN12605000699662
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
1/11/2005
Date last updated
28/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sandostatin LAR in HCC
Scientific title
Pilot Phase II Study of Sandostatin LAR in Patients with Advanced Hepatocellular Carcinoma to assess toxicity and improve survival
Secondary ID [1] 208 0
Australasian Gastro-Intestinal Trials Group: AG0001H
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Hepatocellular Carcinoma 848 0
Condition category
Condition code
Cancer 915 915 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sandostatin LAR for 12 months
Intervention code [1] 542 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1190 0
Compliance with treatment
Timepoint [1] 1190 0
Montly assessments
Primary outcome [2] 1191 0
Compliance with assessments
Timepoint [2] 1191 0
Montly assessments
Secondary outcome [1] 2176 0
Adverse events, including complications of cirrhosis
Timepoint [1] 2176 0
Monthly assessments
Secondary outcome [2] 2177 0
Accrual rate
Timepoint [2] 2177 0
Monthly assessments
Secondary outcome [3] 2178 0
Biopsy rate
Timepoint [3] 2178 0
Monthly assessments
Secondary outcome [4] 2179 0
Somatostatin receptor positivity rate
Timepoint [4] 2179 0
Monthly assessments
Secondary outcome [5] 2180 0
Subjective patient benefit
Timepoint [5] 2180 0
Monthly assessments
Secondary outcome [6] 2181 0
Quality of life
Timepoint [6] 2181 0
Monthly assessments
Secondary outcome [7] 2182 0
Tumour response
Timepoint [7] 2182 0
Monthly assessments
Secondary outcome [8] 2183 0
Time to progression
Timepoint [8] 2183 0
Monthly assessments
Secondary outcome [9] 2184 0
Overall survival
Timepoint [9] 2184 0
Monthly assessments
Secondary outcome [10] 2185 0
Somatostatin receptor status impact on survival
Timepoint [10] 2185 0
Monthly assessments
Secondary outcome [11] 2186 0
Pharmacokinetics of Sandostatin LAR ®
Timepoint [11] 2186 0
Monthly assessments
Secondary outcome [12] 2187 0
Effects of Sandostatin LAR ® on complications of cirrhosis
Timepoint [12] 2187 0
Monthly assessments
Secondary outcome [13] 2188 0
Comparison of methods for quantifying somatostatin receptors.
Timepoint [13] 2188 0
Monthly assessments

Eligibility
Key inclusion criteria
(All of the following): 4.1.1histological OR cytological evidence of hepatocellular carcinoma OR liver imaging suggestive of the diagnosis AND a plasma alpha-fetoprotein over 500 IU/mL. 4.1.2 Hepatocellular carcinoma which is unresectable. 4.1.3patient performance status (WHO) grade 0, 1 or 2.4.1.7women must have a negative pregnancy test prior to treatment; both men and women should have adequate contraception during the course of treatment.4.1.8written informed consent.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(None of the following: )4.2.1Previous octreotide treatment for hepatocellular carcinoma4.2.2patient performance status > (WHO) 3 4.2.3peripheral blood white cell count < 2.0 x 109/L, platelet count <50 x 109/L and haemoglobin < 10.0 g/L.4.2.4serum creatinine greater than or equal to 0.15mmol/L; serum bilirubin > 50 micromol/litre; serum albumin < 25 g/L; AST and ALT > 5x institutional upper limit of normal. Patients with Primary Biliary Cirrhosis (PBC) should be classified using Bilirubin levels defined for this patient group in the Childs-Pugh Score (see appendix 7).4.2.5prothrombin ratio (INR) > 2.04.2.6any inter-current illness that may significantly interfere with safe administration of Sandostatin LAR® or end-point evaluation; including refractory severe encephalopathy, symptomatic gallstone disease (either cholecystolithiasis or choledocholithiasis).4.2.7Treatment with somatostatin for other reasons4.2.8Concurrent anti-tumour treatment for HCC4.2.9pregnant women4.2.10previous malignancy within the last 5 years other than curatively resected non-melanoma skin cancer or carcinoma of the uterine cervix.4.2.11known reaction to the study drug4.2.12HIV positive patients4.2.13uncontrolled ascites requiring paracentesis within 4 weeks4.2.14variceal bleeding in the last month4.2.15prior radiation therapy to the only evaluable site of disease4.2.16refusal to give informed consent to participate in the study4.2.17Child-Pugh class C cirrhosis, (for patients with PBC use the adjusted bilirubin levels to classify the patient).4.2.18patients who are rendered artificially eligible by the administration of blood product support.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1010 0
Commercial sector/Industry
Name [1] 1010 0
Novartis Educational Grant
Address [1] 1010 0
Country [1] 1010 0
Primary sponsor type
Individual
Name
Site - Investigator Initiated
Address
Country
Secondary sponsor category [1] 871 0
Other Collaborative groups
Name [1] 871 0
AGITG
Address [1] 871 0
Country [1] 871 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35303 0
Address 35303 0
Country 35303 0
Phone 35303 0
Fax 35303 0
Email 35303 0
Contact person for public queries
Name 9731 0
Burcu Cakir
Address 9731 0
Locked Bag 77
Camperdown NSW 1450
Country 9731 0
Australia
Phone 9731 0
+61 2 95625334
Fax 9731 0
+61 2 95625094
Email 9731 0
bcakir@ctc.usyd.edu.au
Contact person for scientific queries
Name 659 0
Jonathon Cebon
Address 659 0
Ludwig Institute of Cancer Research
Austin and Repatriation Medical Centre (A&RMC)
Melbourne VIC 3084
Country 659 0
Australia
Phone 659 0
+61 2 95625334
Fax 659 0
Email 659 0
jonathan.cebon@ludwig.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary