CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 85 enrolled
Drug / intervention
Octreotide LAR (Long-acting release) +1 moredrug
Likely dose
Octreotide LAR 30 mg intramuscularly every 28 daysAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed locally inoperable or metastasized well-differentiated neuroendocrine tumor of the midgut
  • ✓Curative surgery not possible
  • ✓Two-dimensional tumor measurable by CT or MRI
  • ✓Age ≥18 years
Key exclusion· 7
  • ✕Hypersensitivity to octreotide
  • ✕Poorly differentiated or small cell neuroendocrine tumors
  • ✕Primary tumor outside the midgut
  • ✕Prior somatostatin-analogue treatment >4 weeks

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00171873
NCT00171873Phase 3Completed
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Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut

Carmen Schade-Brittinger·interventional·Posted Sep 15, 2005·Updated Mar 26, 2020

In Brief

A Phase 3 clinical trial evaluating Octreotide LAR (Long-acting release) and Placebo for Neuroendocrine Tumors. Completed, enrolled 85 participants across 10 sites.

Detailed Summary

Placebo-controlled prospective randomized phase III study to investigate the antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of the midgut

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroendocrine Tumors
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartSep 1, 2001
Primary CompletionJun 1, 2008
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 20.8 years ago

Interventions

Octreotide LAR (Long-acting release)drug

30 mg intramuscularly every 28 days

Placebodrug

Sodium chloride intramuscularly every 28 days