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Real-world Study on Adjuvant Octreotide Therapy in pNETs

Sponsor
Changhai Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06080204
Collaborator
(none)
411
Enrollment
2
Arms
145
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Octreotide LAR
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
411 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Real-world Effectiveness of Adjuvant Octreotide Therapy in High Recurrence Risk Patients With Pancreatic Neuroendocrine Tumors
Actual Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
Apr 1, 2020
Actual Study Completion Date :
Apr 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Octreotide group

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.

Drug: Octreotide LAR
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。
Other Names:
  • Sandostatin

    		•
    No Intervention: Control group

    No adjuvant therapy after surgery.

    Outcome Measures

    Primary Outcome Measures

    1. Disease-free survival time [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]

      Disease-free survival time

    Secondary Outcome Measures

    1. Overall survival time [From the date of surgery to the date of death due to any cause, whichever came first, assessed up to 120 months]

      Overall survival time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Changhai Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guo ShiWei, Clinical Professor, Changhai Hospital
    ClinicalTrials.gov Identifier:
    NCT06080204
    Other Study ID Numbers:
    • ChanghaiH-PP12
    First Posted:
    Oct 12, 2023
    Last Update Posted:
    Oct 18, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neuroendocrine Tumors
    Adenoma, Islet Cell
    Octreotide

    Study Results

    No Results Posted as of Oct 18, 2023