Trial · NCT00171873
Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
NCT00171873, Phase 3, Completed, Carmen Schade-Brittinger; results first posted 2011-03-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut. Trials, record NCT00171873. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00171873
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
- NCT number
- NCT00171873
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 85 participants, actual
- Lead sponsor
- Carmen Schade-Brittinger
- Conditions
- Neuroendocrine Tumors
- Interventions
- Octreotide LAR (Long-acting release), Placebo
- First posted
- 2005-09-15
- Last updated
- 2020-03-26
- Results first posted
- 2011-03-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) | Up to 7 years | Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008. |
| Secondary | Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals | at 3 month intervals | |
| Secondary | Biochemical Response at 3 Month Intervals | at 3 month intervals up to 18 moths | |
| Secondary | Symptom Control at 3 Month Intervals | at 3 month intervals up to 18 moths | |
| Secondary | Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study | at three-month intervals | |
| Secondary | Survival | at least on a monthly basis |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) | Up to 7 years | Conservative Intent to Treat (ITT) population consisting of all participants who received study drug. 3 participants in the Octreotide group and 1 participant in the placebo group without liver involvement at the beginning of the study were excluded from this analysis. | Months | MEDIAN |
| SECONDARY | Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals | at 3 month intervals | |||
| SECONDARY | Biochemical Response at 3 Month Intervals | at 3 month intervals up to 18 moths | |||
| SECONDARY | Symptom Control at 3 Month Intervals | at 3 month intervals up to 18 moths | |||
| SECONDARY | Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study | at three-month intervals | |||
| SECONDARY | Survival | at least on a monthly basis |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) | Octreotide LAR (SMS995) | 14.3 | 95% Confidence Interval 11.0 to 28.8 | Months | |
| Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) | Placebo | 6.0 | 95% Confidence Interval 3.7 to 9.4 | Months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Octreotide LAR (SMS995) | 42 | |
| Overall Study | STARTED | Placebo | 43 | |
| Overall Study | COMPLETED | Octreotide LAR (SMS995) | 33 | |
| Overall Study | COMPLETED | Placebo | 40 | |
| Overall Study | NOT COMPLETED | Octreotide LAR (SMS995) | 9 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastrointestinal disorders | Gastrointestinal disorders | Octreotide LAR (SMS995) | 6 | 42 | |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Placebo | 8 | 43 | |
| other | Hematopoietic system | Blood and lymphatic system disorders | Octreotide LAR (SMS995) | 5 | 42 | |
| other | Hematopoietic system | Blood and lymphatic system disorders | Placebo | 1 | 43 | |
| other | General Health | General disorders | Octreotide LAR (SMS995) | 8 | 42 | |
| other | General Health | General disorders | Placebo | 2 | 43 | |
| serious | General Disorder | General disorders | Octreotide LAR (SMS995) | 11 | 42 | |
| serious | General Disorder | General disorders | Placebo | 10 | 43 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Octreotide LAR (SMS995) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Octreotide LAR (SMS995) | 19 | 42 |
| Total, other adverse events | Placebo | 11 | 43 |
| Total, serious adverse events | Octreotide LAR (SMS995) | 11 | 42 |
| Total, serious adverse events | Placebo | 10 | 43 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19704057 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Octreotide LAR (SMS995) vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00171873
GET https://conductscience.org/api/trials/v1/NCT00171873/registered