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Clinical trial

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

ID
Name
ChanghaiH-PP12
Description
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.
Trial arms
Trial start
2008-03-01
Estimated PCD
2020-04-01
Trial end
2020-04-01
Status
Completed
Treatment
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。
Arms:
Octreotide group
Other names:
Sandostatin
Size
411
Primary endpoint
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
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 411, 'type': 'ACTUAL'}}
Updated at
2023-10-18

1 organization

1 product

1 indication

Organization
Changhai Hospital
Product
Octreotide
Indication
Pancreatic Neuroendocrine Tumor Grade 2