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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase: Terminated; Phase 4

Conditions: Carcinoid Syndrome; Neuroendocrine Tumors

Treatments: Drug: Sandostatin

Study type: Interventional

Funder types: Other

Identifiers

NCT04140409

SCIROCCO

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment

Experimental group

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.

Treatment:

Drug: Sandostatin