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Slow recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sandostatin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment succes vs treatment failure | The primary endpoint is defined as follows:
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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivan Borbath, Prof | Cliniques Universitaires St-Luc | Principal Investigator |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D020230 | Serotonin Syndrome |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| 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 |
| D009380 | Neoplasms, Nerve Tissue |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D000602 |
| Amino Acids, Peptides, and Proteins |