← Human Trials & Peer-Reviewed Studies
Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma
Plain-language guide to NCT00332969: phase 2 interventional trial of Octreotide, 25 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00332969
- Phase
- phase 2
- Status
- completed
- Start
- 2005-09
- Completion (planned or actual)
- 2010-10
- Participants
- 25 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Thymoma
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Octreotide.
It had 1 arm (groups): Sandostatin (experimental).
The registry classes the interventions as drug.
Who Took Part
25 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female patients aged \>18 years. Inoperability of thymic tumor. Inoperability is defined as at least adherence of the tumor to the neighbour organs, suspicious to infiltrate neighbour organs so that R0 resection cannot be expected. Positive result in SMS-szintigraphy,. Thymomas of all WHO based histological subtypes (Rosai, 1999; Travis 2004) at Masaoka stage III based on histological examination of core biopsies or resection specimens. Patients with and without thymoma associated paraneoplastic syndrome.
The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: performance status 0,1, or 2 (ecog); symptomatic cholelithiasis,; pretreatment with octreotide (longn acting release) within the 3 months.
How the Study Was Run
The set-up was single-group and open-label.
Being open-label, the Octreotide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2005-09 with completion listed for 2010-10.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Shrinkage of tumor size and diameter of 3 respectively 6 months (time frame: 6 months).
It also tracked 1 secondary outcome, for example Resection status after 3 respectively 6 months.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Octreotide in 25 people.
Its size is small, so on its own it can only give an early look.
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.