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Neuroendocrine TumorsPhase 4SCIROCCONCT04140409

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

A Phase 4 study testing Sandostatin in people with Neuroendocrine Tumors and Carcinoid Syndrome, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Tumors, Carcinoid Syndrome
What is being tested?
Sandostatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
2 Feb 2016to 19 Sep 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: 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

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.

Being tested
Sandostatin
Keywords
NET
Medical subject headings
Neuroendocrine Tumors, Serotonin Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SandostatinDrug

    Also called Octreotide LAR

    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.

Study groups in NCT04140409
Study groupRoleWhat they receive
TreatmentExperimentalAll 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.
Receives: Drug: Sandostatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

Secondary outcomes (7)

  1. Symptoms

    To describe the number of symptoms in correlation to the serum octreotide level, defined by a blood level test of octreotide.

    Measured: 2 years

  2. Rate of diarrhea and flushes

    To describe the rate of diarrhea and flushing via a patient diary

    Measured: 2 years

  3. Impact of increased dose

    To describe the impact of increased dose of octreotide LAR on the symptoms: bowel movements and flushing (via patient diary).

    Measured: 2 years

  4. 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

    Measured: 2 years

  5. Effect on tumor control

    To describe the effect of Octreotide LAR on tumor control according to RECIST 1.1 criteria

    •

    Measured: 2 years

  6. Toxicities

    To describe the safety of octreotide (CTCAE grades)

    Measured: 2 years

  7. Correlation dose/frequency

    To describe the correlation between the dose/frequency of octreotide LAR given and the serum octreotide level.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2019
  2. Study start2 Feb 2016
  3. Primary completion30 Jun 2019
  4. Study completion19 Sep 2019

Why it stopped: Slow recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04140409
Sponsor's protocol ID
SCIROCCO
Acronym
SCIROCCO
Status last verified
Oct 2019
First submitted
22 Oct 2019
Last updated
25 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sandostatin in people with Neuroendocrine Tumors and Carcinoid Syndrome, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment succes vs treatment failure (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04140409.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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