Real-world Study on Adjuvant Octreotide Therapy in pNETs

Pancreatic Neuroendocrine Tumor G2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06080204
• Other study ID #: ChanghaiH-PP12
• Status: Completed
• Phase: N/A
• Start date: March 2008
• Est. completion date: April 2020

Study information

• Verified date: September 2023
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Pancreatic Neuroendocrine Tumor G2

Intervention

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?

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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