Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04140409
Recruitment Status : Terminated (Slow recruitment)
First Posted : October 25, 2019
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Carcinoid Syndrome Drug: Sandostatin Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2, 2016
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : September 19, 2019


Arm Intervention/treatment
Experimental: Treatment
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
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.
Other Name: Octreotide LAR




Primary Outcome Measures :
  1. Treatment succes vs treatment failure [ Time Frame: 2 years ]

    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.



Secondary Outcome Measures :
  1. Symptoms [ Time Frame: 2 years ]
    To describe the number of symptoms in correlation to the serum octreotide level, defined by a blood level test of octreotide.

  2. Rate of diarrhea and flushes [ Time Frame: 2 years ]
    To describe the rate of diarrhea and flushing via a patient diary

  3. Impact of increased dose [ Time Frame: 2 years ]
    To describe the impact of increased dose of octreotide LAR on the symptoms: bowel movements and flushing (via patient diary).

  4. Changes in Quality of life [ Time Frame: 2 years ]
    To describe the effect of Octreotide LAR on Quality of Life, based on the change from baseline in the OLO-GINET21 scores

  5. Effect on tumor control [ Time Frame: 2 years ]

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


  6. Toxicities [ Time Frame: 2 years ]
    To describe the safety of octreotide (CTCAE grades)

  7. Correlation dose/frequency [ Time Frame: 2 years ]
    To describe the correlation between the dose/frequency of octreotide LAR given and the serum octreotide level.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140409


Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Layout table for investigator information
Principal Investigator: Ivan Borbath, Prof Cliniques Universitaires St-Luc
Layout table for additonal information
Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT04140409    
Other Study ID Numbers: SCIROCCO
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
NET
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Carcinoid Tumor
Malignant Carcinoid Syndrome
Syndrome
Serotonin Syndrome
Disease
Pathologic Processes
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents