Real-world Study on Adjuvant Octreotide Therapy in pNETs

Study Overview
=================
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.

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

Conditions
-----------------
Pancreatic Neuroendocrine Tumor G2

Intervention / Treatment
-----------------
* Drug: Octreotide LAR


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Octreotide group<br>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<br>* 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。<br>* Other names: Sandostatin;|
| No Intervention: Control group<br>No adjuvant therapy after surgery. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival time | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival time | 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 |