Real-world Study on Adjuvant Octreotide Therapy in pNETs

NCT06080204 | Completed

• 1 other identifier: ChanghaiH-PP12
• Study Type: interventional
• Target: 411
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Neuroendocrine Tumor G2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Octreotide group

EXPERIMENTAL

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

Control group

NO INTERVENTION

No adjuvant therapy after surgery.

Interventions

Octreotide LAR 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。

Also known as: Sandostatin

Octreotide group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Stage IV
• Other oncological history
• Previous antineoplastic systemic therapy
• Lack of information/details on recurrence or death.

Sponsors & Collaborators

• Changhai Hospital: lead

MeSH Terms

Interventions

Octreotide

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 12, 2023
• Study Start: March 1, 2008
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: October 18, 2023

Record last verified: 2023-09