Clinical trial · Interventional
Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation
Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation A Prospective Interventional Trial of Patients With Neuro-endocrine Tumors With Carcinoid Syndrome Receiving Octreotide LAR
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment
Summary
Brief summary (as posted)
This is a multi-centric prospective interventional study in which patients with a symptomatic GEP-NET will receive octreotide LAR every 2, 3 or 4 weeks. The basal dose and the dose adaptation will be left at the discretion of the investigator depending on the rate of symptom control. Dose increase up to doses of 60 mg octreotide every 4 weeks, or increase of frequency up to 30 mg every 2 weeks can be done to obtain control of carcinoid symptoms, defined by at least a 50% decrease of the mean number of bowel movements per day and the total number of flushes over 7 days AND a maximum frequency of less than 4 bowel movements a day. If only one symptom is present, analysis will be done for that symptom only: refer to table in statistical analysis The concentration of serum octreotide level will be realized with LCMS/MS following the method of Capron \& Wallemacq. Each blood sample should be taken 4 times per year just before the next injection of Octreotide LAR.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoid Syndrome | — | UNRESOLVED | — |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sandostatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- All patients will be treated with octreotide LAR intramuscular injections at maximum doses of 60 mg every 4 weeks or a frequency up to 30 mg octreotide LAR each 2 weeks. Change of dose or frequency is left at the discretion of the investigator until symptom control is obtained.
- interventionNames
- Drug: Sandostatin
Primary outcomes (1)
- measure
- Treatment succes vs treatment failure
- timeFrame
- 2 years
- description
- The primary endpoint is defined as follows: * Treatment success: Symptom control is achieved within 2 years of treatment with octreotide LAR. Symptom control is defined as at least a 50% decrease of the mean number of bowel movements per day and the total number of flushes over 7 days AND a maximum frequency of less than 4 bowel movements a day. * Treatment failure: No symptom control is achieved within 2 years of treatment with octreotide LAR. The response rate will be calculated as the number of patients with treatment success divided by the total number of included patients that received at least one injection of octreotide LAR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent GEP NET Ki 67 ≤ 10 % * Histologically or cytologically confirmed GEP NET * Appearance of carcinoid syndrome maximum 6 months before the inclusion * Evaluable or measurable disease (RECIST 1.1) WHO ECOG performance status 0-2 * Positive somatostatin receptor scintigraphy * \>18 years * Life expectancy of at least 12 weeks Exclusion Criteria: * Uncontrolled concurrent disease which prevents the adequate management and follow-up of the NET. * Previous malignancy in the last past 3 years except malignancies estimated as completely cured. * Current pregnancy or breast feeding * Concomitant anti-tumoral treatment, except external beam radiotherapy
References
Publications (0)
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