Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Neuroendocrine Tumors, Carcinoid Syndrome

Intervention / Treatment
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* Drug: Sandostatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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. | Drug: Sandostatin<br>* 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.<br>* Other names: Octreotide LAR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment succes vs treatment failure | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms | To describe the number of symptoms in correlation to the serum octreotide level, defined by a blood level test of octreotide. | 2 years | 
| Rate of diarrhea and flushes | To describe the rate of diarrhea and flushing via a patient diary | 2 years | 
| Impact of increased dose | To describe the impact of increased dose of octreotide LAR on the symptoms: bowel movements and flushing (via patient diary). | 2 years | 
| Changes in Quality of life | To describe the effect of Octreotide LAR on Quality of Life, based on the change from baseline in the OLO-GINET21 scores | 2 years | 
| Effect on tumor control | To describe the effect of Octreotide LAR on tumor control according to RECIST 1.1 criteria • | 2 years | 
| Toxicities | To describe the safety of octreotide (CTCAE grades) | 2 years | 
| Correlation dose/frequency | To describe the correlation between the dose/frequency of octreotide LAR given and the serum octreotide level. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NET