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

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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

Tracking Information
First Submitted Date  ICMJE October 22, 2019
First Posted Date  ICMJE October 25, 2019
Last Update Posted Date October 25, 2019
Actual Study Start Date  ICMJE February 2, 2016
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2019)
  • 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.
  • Rate of diarrhea and flushes [ Time Frame: 2 years ]
    To describe the rate of diarrhea and flushing via a patient diary
  • 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).
  • 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
  • Effect on tumor control [ Time Frame: 2 years ]
    To describe the effect of Octreotide LAR on tumor control according to RECIST 1.1 criteria •
  • Toxicities [ Time Frame: 2 years ]
    To describe the safety of octreotide (CTCAE grades)
  • Correlation dose/frequency [ Time Frame: 2 years ]
    To describe the correlation between the dose/frequency of octreotide LAR given and the serum octreotide level.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuroendocrine Tumors
  • Carcinoid Syndrome
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Sandostatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 24, 2019)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 19, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04140409
Other Study ID Numbers  ICMJE SCIROCCO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor  ICMJE Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ivan Borbath, Prof Cliniques Universitaires St-Luc
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP