NCT00386984

Brief Summary

A preliminary study has shown that the hormone-similar, growth-retarding drug octreotide can prolong survival time in patients with primary liver cancer. Due to methodological deficiencies of the preliminary study the results will be re-checked by the comparison of octreotide with an pseudo-drug (so-called placebo) primarily regarding to the survival time and secondarily concerning costs, side effects, patient cooperation and quality of life as well as specific conditions in the tumor tissue in both groups with 108 patients with primary liver cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 1999

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 12, 2006

Completed
Last Updated

October 12, 2006

Status Verified

October 1, 2006

First QC Date

October 11, 2006

Last Update Submit

October 11, 2006

Conditions

Carcinoma, Hepatocellular

Keywords

hepatocellular carcinoma; Sandostatin-LAR; RCT

Outcome Measures

Primary Outcomes (1)

  • Overall survival time

Secondary Outcomes (6)

  • Costs of the treatment measured by days of in-patient treatment

  • Side effects

  • Patient compliance

  • Quality of life

  • Somatostatin receptors in the tumor tissue

  • +1 more secondary outcomes

Interventions

Somatostatin (octreotide)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inoperable patients
  • histologically confirmed HCC or patients who refuse surgery and who otherwise (e.g. due to the advanced tumor stage) are not applicable for palliative local therapy (e.g. PEI, TACE, RFTA).
  • Age: 18 years or older

You may not qualify if:

  • General:
  • Patient with symptomatic Cholecyst-/Choledocholithiasis
  • Patient with severe psychiatric disease.
  • Participation in another clinical trial within the last 4 weeks.
  • Simultaneous participation in another clinical examination.
  • Legally incapacitated patient, who is not able, to understand nature, meaning and consequence of the study.
  • Continuous drug or alcohol abuse.
  • Patient with known HIV infection and antiretroviral therapy.
  • Patient with not controllable infection disease.
  • Pregnancy.
  • Secondary malignant tumor without complete remission.
  • Secondary malignant tumor with complete remission but current adjuvant therapy.
  • Preliminary or current therapy with tamoxifen
  • Pretreatment of the HCC.
  • Severe hepatic encephalopathy, refractory to any treatment.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Related Publications (1)

  • Allgaier HP, Becker G, Blum HE. [A therapeutic study of hepatocellular carcinoma using octreotide (HECTOR). Hepatocellular Carcinoma: Treatment with Octreotide]. Dtsch Med Wochenschr. 2000 Mar 17;125(11):320. No abstract available. German.

    PMID: 10761474RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

SomatostatinOctreotide

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPancreatic HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteinsPeptides, CyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Hans-Peter Allgaier, PD

    Evangelischen Diakoniekrankenhaus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 11, 2006

First Posted

October 12, 2006

Study Start

October 1, 1999

Study Completion

February 1, 2003

Last Updated

October 12, 2006

Record last verified: 2006-10

Locations

DE(1)