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Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
Plain-language guide to NCT00075868: phase 3 randomized trial of Octreotide, 233 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00075868
- Phase
- phase 3
- Status
- completed
- Start
- 2003-12
- Completion (planned or actual)
- 2006-08
- Participants
- 233 (actual)
- Design
- randomized, double-blind, supportive_care
- Conditions studied
- Anal Cancer; Colorectal Cancer; Drug/Agent Toxicity by Tissue/Organ; Radiation Enteritis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Octreotide.
It had two arms (groups): Sandostatin LAR® Depot (experimental) and Placebo (placebo comparator).
Sandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days).
Placebo Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days).
The registry classes the interventions as drug and other.
More on the Plan
OUTLINE: This is a double-blind, placebo-controlled, randomized, multicenter study.
NOTE: \*Patients receive a total of 2 injections of octreotide or placebo In both arms, treatment continues in the absence of unacceptable toxicity.
PROJECTED ACCRUAL: A total of 226 patients (113 per treatment arm) will be accrued for this study within 2 years.
Who Took Part
The registry lists 233 actual participants took part.
It was open to people of any sex aged from 18 years up to 120 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: No metastasis beyond the pelvic regional nodes. 18 and over. Liver function tests \< 3 times upper limit of normal. No prior hepatic disease. No prior chronic or acute regional enteritis.
The full record lists 41 inclusion and 0 exclusion criteria.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
As a double-blind Octreotide study, the assignments were hidden from both participants and investigators until the end.
It started in 2003-12 with completion listed for 2006-08.
It ran at 112 sites in United States (112).
Its stated primary purpose is supportive care.
What Was Measured
It also tracked 4 secondary outcomes, for example Quality of life and Economic measures.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Octreotide in 233 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.