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Real-world Study on Adjuvant Octreotide Therapy in pNETs
Plain-language guide to NCT06080204: not phased non-randomized trial of Octreotide, 411 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06080204
- Phase
- not phased
- Status
- completed
- Start
- 2008-03
- Completion (planned or actual)
- 2020-04
- Participants
- 411 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Pancreatic Neuroendocrine Tumor G2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Octreotide.
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.
It had two arms (groups): Octreotide group (experimental) and Control group (no intervention).
No adjuvant therapy after surgery.
The registry classes the interventions as drug.
More on the Plan
To address this unmet clinical need, the investigators initiated this real-world study.
Who Took Part
Enrollment: 411 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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.
The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: stage iv; other oncological history; previous antineoplastic systemic therapy.
How the Study Was Run
The set-up was non-randomized, parallel-group and open-label.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Octreotide study did not mask who received what.
It started in 2008-03 with completion listed for 2020-04.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Disease-free survival time.
It also tracked 1 secondary outcome, for example Overall survival time.
What This Means in Plain Language
Put simply, this is a not phased, non-randomized trial of Octreotide in 411 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Octreotide compound page, all human trials.
Our Notes on the Compound
Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.