Real-world Study on Adjuvant Octreotide Therapy in pNETs

NCT ID: NCT06080204

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 411 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2020-04-30

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.

Conditions

Pancreatic Neuroendocrine Tumor G2

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Octreotide LAR

Intervention Type: DRUG

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。

Control group

No adjuvant therapy after surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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。

Intervention Type: DRUG

Other Intervention Names

Sandostatin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guo ShiWei

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ChanghaiH-PP12

Identifier Type: -

Identifier Source: org_study_id