Real-world Study on Adjuvant Octreotide Therapy in pNETs

Real-world Effectiveness of Adjuvant Octreotide Therapy in High Recurrence Risk Patients With Pancreatic Neuroendocrine Tumors

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06080204

Enrollment

411

Registered

2023-10-12

Start date

2008-03-31

Completion date

2020-04-30

Last updated

2023-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neuroendocrine Tumor G2

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.

Interventions

DRUGOctreotide 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。

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026