Clinical trial · Interventional
Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
NCT00171873CI-TRIAL-00044278completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Placebo-controlled prospective randomized phase III study to investigate the antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of the midgut
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Octreotide LAR (Long-acting release) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Octreotide LAR (Long Acting Release)
- description
- Octreotide LAR 30 mg intramuscularly every 28 days
- interventionNames
- Drug: Octreotide LAR (Long-acting release)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo - Sodium chloride intramuscularly every 28 days
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
- timeFrame
- Up to 7 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Therapy-naive patients with histologically confirmed diagnosis of a locally inoperable or metastasized well-differentiated neuroendocrine tumor of the midgut * curative surgery impossible * two-dimensional tumor formation assessable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) * Age ≥ 18 * Karnofsky-index \> 60 * written informed consent * proliferation index for Ki67 Exclusion Criteria: * hypersensitivity to octreotide * poorly differentiated or small cell neuroendocrine tumors * primary tumor outside of the midgut * prior treatment with somatostatin-analogue \> 4 weeks * prior treatment with alpha-interferon, chemotherapy, or chemoembolisation * participation in any other clinical trial * pregnancy or lactation * no secondary malignancy in anamnesis; with the exception of patients without any manifestation of the secondary malignancy (without relapse) after curative therapy within the last five years * severe decompensated organ malfunction (heart-, liver- insufficiency) Other protocol-defined exclusion criteria may apply.
References
Publications (1)
- DERIVEDRinke A, Muller HH, Schade-Brittinger C, Klose KJ, Barth P, Wied M, Mayer C, Aminossadati B, Pape UF, Blaker M, Harder J, Arnold C, Gress T, Arnold R; PROMID Study Group. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol. 2009 Oct 1;27(28):4656-63. doi: 10.1200/JCO.2009.22.8510. Epub 2009 Aug 24. PMID 19704057