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Completed

NCT Number: NCT06080204

Real-world Study on Adjuvant Octreotide Therapy in pNETs

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.

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Key information

Conditions

Pancreatic Neuroendocrine Tumor G2

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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。

Other names: Sandostatin

Primary outcomes

  1. Disease-free survival time

    Time frame: 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

    Disease-free survival time

Secondary outcomes

  1. Overall survival time

    Time frame: From the date of surgery to the date of death due to any cause, whichever came first, assessed up to 120 months

    Overall survival time

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2020
Study completion
2020
First posted
Oct 12, 2023
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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