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Real-world Study on Adjuvant Octreotide Therapy in pNETs

Primary Purpose

Pancreatic Neuroendocrine Tumor G2

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Octreotide LAR
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neuroendocrine Tumor G2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: pNETs lesions pathologically classified as WHO grade 2 Complete surgical resection (R0 or R1 was achieved) Adjuvant treatment was performed within 12 weeks after surgery Exclusion Criteria: Stage IV Other oncological history Previous antineoplastic systemic therapy Lack of information/details on recurrence or death.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Octreotide group

    Control group

    Arm Description

    Patients in the octreotide group received octreotide LAR (Sandostatin® LAR, Novartis Pharmaceuticals Corporation) treatment by deep intramuscular injection at a dose of 30 mg every 28 days for 6-12 months, with the start of clinical intervention following surgery.

    No adjuvant therapy after surgery.

    Outcomes

    Primary Outcome Measures

    Disease-free survival time
    Disease-free survival time

    Secondary Outcome Measures

    Overall survival time
    Overall survival time

    Full Information

    First Posted
    September 26, 2023
    Last Updated
    October 17, 2023
    Sponsor
    Changhai Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06080204
    Brief Title
    Real-world Study on Adjuvant Octreotide Therapy in pNETs
    Official Title
    Real-world Effectiveness of Adjuvant Octreotide Therapy in High Recurrence Risk Patients With Pancreatic Neuroendocrine Tumors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2008 (Actual)
    Primary Completion Date
    April 2020 (Actual)
    Study Completion Date
    April 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Changhai Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Adjuvant therapy in pancreatic neuroendocrine tumors (pNETs) after radical resection lacks evidence-based data and is controversial. Real-world data were clustered to validate whether the long-acting octreotide is a potential candidate for adjuvant therapy in high recurrence risk G2 pNET patients.
    Detailed Description
    Adjuvant therapy for pNETs was proposed as an unmet clinical need by the European Neuroendocrine Tumor Society Group in 2016.1The Clinical Practice Guidelines for pNETs in China recommended initiation of clinical trials to investigate the role of adjuvant therapy for patients with a high-risk of recurrence. To address this unmet clinical need, the investigators initiated this real-world study. The aim of the current study was to assess the impact of octreotide LAR as an adjuvant therapy in reducing recurrence and prolonging survival in Chinese non-metastatic pNETs patients at risk for recurrence.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Neuroendocrine Tumor G2

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    411 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Octreotide group
    Arm Type
    Experimental
    Arm Description
    Patients in the octreotide group received octreotide LAR (Sandostatin® LAR, Novartis Pharmaceuticals Corporation) treatment by deep intramuscular injection at a dose of 30 mg every 28 days for 6-12 months, with the start of clinical intervention following surgery.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    No adjuvant therapy after surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Octreotide LAR
    Other Intervention Name(s)
    Sandostatin
    Intervention Description
    Octreotide LAR (Sandostatin® LAR, Novartis Pharmaceuticals Corporation) treatment by deep intramuscular injection at a dose of 30 mg every 28 days for 6-12 months。
    Primary Outcome Measure Information:
    Title
    Disease-free survival time
    Description
    Disease-free survival time
    Time Frame
    From the date of surgery to the date of distant metastasis or recurrence or death due to any cause, whichever came first, assessed up to 120 months
    Secondary Outcome Measure Information:
    Title
    Overall survival time
    Description
    Overall survival time
    Time Frame
    From the date of surgery to the date of death due to any cause, whichever came first, assessed up to 120 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: pNETs lesions pathologically classified as WHO grade 2 Complete surgical resection (R0 or R1 was achieved) Adjuvant treatment was performed within 12 weeks after surgery Exclusion Criteria: Stage IV Other oncological history Previous antineoplastic systemic therapy Lack of information/details on recurrence or death.

    12. IPD Sharing Statement

    Learn more about this trial

    Real-world Study on Adjuvant Octreotide Therapy in pNETs

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