Real-world Study on Adjuvant Octreotide Therapy in pNETs

Not Applicable

Completed

• Conditions: Pancreatic Neuroendocrine Tumor G2
• Interventions: Drug: Octreotide LAR

• Registration Number: NCT06080204
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2020-04
• Study Completion: 2020-04
• Status Verified: 2023-09
• Study First Submitted: 2023-09-26
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-12
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 411

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Octreotide group	Octreotide LAR	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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