Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group.

Rinke A, Müller HH, Schade-Brittinger C, Klose KJ, Barth P, Wied M, Mayer C, Aminossadati B, Pape UF, Bläker M, Harder J, Arnold C, Gress T, Arnold R

Journal of clinical oncology : official journal of the American Society of Clinical Oncology24 Aug 2009Cited by 1,700 (Europe PMC)

PMID19704057DOI10.1200/jco.2009.22.8510PepBankPUB-19704057

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In metastatic midgut NETs, octreotide prolonged median progression time to 14.3 versus 6 months (HR 0.34; 95% CI 0.20-0.59; P=.000072).
In plain wordsIn metastatic midgut tumors, octreotide prolonged time to progression compared with placebo.
Peptide
Octreotide
Outcome
IncreaseTime to tumor progression
Study
n = 85
Comparator
Placebo
Analysis
Primary
Outcome group
Tumor growth · Cancer
Studied dose
30 mg monthly · intramuscularAs given in this study (human).
Measurements
Median time to tumor progression
14.3 months
octreotide LAR group
Median time to tumor progression
6 months
placebo group
Hazard ratio
0.34 HR
octreotide LAR versus placebo
95% CI of hazard ratio
0.2 to 0.59
octreotide LAR versus placebo
P value
0.000072 P
octreotide LAR versus placebo
Source sentences
Summary
Median time to tumor progression in the octreotide LAR and placebo groups was 14.3 and 6 months, respectively (hazard ratio [HR] = 0.34; 95% CI, 0.20 to 0.59; P = .000072).
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a placebo-controlled, double-blind, phase IIIB study in patients with well-differentiated metastatic midgut NETs.
Summary · context
Treatment-naive patients were randomly assigned to either placebo or octreotide LAR 30 mg intramuscularly in monthly intervals until tumor progression or death.
Report a problemFND-1970405701
02HumanRandomized controlled trialEfficacy outcome
In metastatic midgut NETs, stable disease occurred in 66.7% with octreotide versus 37.2% with placebo after 6 months.
In plain wordsIn metastatic midgut tumors, stable disease was more frequent with octreotide than placebo.
Peptide
Octreotide
Outcome
IncreaseStable disease at six months
Study
n = 85
Comparator
Placebo
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
30 mg monthly · intramuscular · 6 monthsAs given in this study (human).
Measurements
Stable disease rate at 6 months
66.7%
octreotide LAR group
Stable disease rate at 6 months
37.2%
placebo group
Source sentences
Summary
After 6 months of treatment, stable disease was observed in 66.7% of patients in the octreotide LAR group and 37.2% of patients in the placebo group.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a placebo-controlled, double-blind, phase IIIB study in patients with well-differentiated metastatic midgut NETs.
Summary · context
Treatment-naive patients were randomly assigned to either placebo or octreotide LAR 30 mg intramuscularly in monthly intervals until tumor progression or death.
Report a problemFND-1970405702
03HumanRandomized controlled trialEfficacy outcome
In metastatic midgut NETs, the overall-survival hazard ratio for octreotide versus placebo was 0.81 (95% CI 0.30-2.18).
In plain wordsIn metastatic midgut tumors, octreotide's survival hazard estimate versus placebo was uncertain.
Peptide
Octreotide
Outcome
DecreaseOverall survival hazard
Study
n = 85
Comparator
Placebo
Analysis
Secondary
Outcome group
Mortality · Cancer
Studied dose
30 mg monthly · intramuscularAs given in this study (human).
Measurements
Hazard ratio for overall survival
0.81 HR
octreotide LAR versus placebo
95% CI of hazard ratio for overall survival
0.3 to 2.18 HR
octreotide LAR versus placebo
Source sentences
Summary
The HR for overall survival was 0.81 (95% CI, 0.30 to 2.18).
3 context sentences(design, population, supporting numbers)
Summary · context
Because of the low number of observed deaths, survival analysis was not confirmatory.
Summary · context
We performed a placebo-controlled, double-blind, phase IIIB study in patients with well-differentiated metastatic midgut NETs.
Summary · context
Treatment-naive patients were randomly assigned to either placebo or octreotide LAR 30 mg intramuscularly in monthly intervals until tumor progression or death.
Report a problemFND-1970405706
04HumanRandomized controlled trialSafety outcome
In metastatic midgut NETs, seven deaths occurred with octreotide versus nine with placebo.
In plain wordsIn metastatic midgut tumors, seven deaths occurred with octreotide versus nine with placebo.
Peptide
Octreotide
Outcome
DecreaseObserved deaths
Study
n = 85
Comparator
Placebo
Outcome group
Mortality · Cancer
Studied dose
30 mg monthly · intramuscularAs given in this study (human).
Measurements
Deaths
7 deaths
octreotide LAR group
Deaths
9 deaths
placebo group
Source sentences
Summary
Seven and nine deaths were observed in the octreotide LAR and placebo groups, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a placebo-controlled, double-blind, phase IIIB study in patients with well-differentiated metastatic midgut NETs.
Summary · context
Treatment-naive patients were randomly assigned to either placebo or octreotide LAR 30 mg intramuscularly in monthly intervals until tumor progression or death.
Report a problemFND-1970405705
05HumanObservational studyEfficacy outcome
In the octreotide LAR versus placebo trial in metastatic midgut NETs, functionally active and inactive tumors responded similarly.
In plain wordsIn the octreotide trial in metastatic midgut tumors, functionally active and inactive tumors responded similarly.
Peptide
Octreotide
Outcome
Direction not reportedResponse by functional activity
Study
n: not reported in source
Comparator
Functionally inactive tumors
Outcome group
Tumor growth · Cancer
Studied dose
30 mg monthly · intramuscularAs given in this study (human).
Source sentences
Summary
Functionally active and inactive tumors responded similarly.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a placebo-controlled, double-blind, phase IIIB study in patients with well-differentiated metastatic midgut NETs.
Summary · context
Treatment-naive patients were randomly assigned to either placebo or octreotide LAR 30 mg intramuscularly in monthly intervals until tumor progression or death.
Report a problemFND-1970405703
06HumanObservational studyEfficacy outcome
In metastatic midgut NETs, octreotide showed the most favorable effect with low hepatic tumor load and resected primary tumors.
In plain wordsOctreotide effects were most favorable in midgut tumor patients with low liver tumor burden and removed primary tumors.
Peptide
Octreotide
Outcome
Direction not reportedResponse by hepatic burden and resection
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
30 mg monthly · intramuscularAs given in this study (human).
Source sentences
Summary
The most favorable effect was observed in patients with low hepatic tumor load and resected primary tumor.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a placebo-controlled, double-blind, phase IIIB study in patients with well-differentiated metastatic midgut NETs.
Summary · context
Treatment-naive patients were randomly assigned to either placebo or octreotide LAR 30 mg intramuscularly in monthly intervals until tumor progression or death.
Report a problemFND-1970405704

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00171873

Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut

Carmen Schade-Brittingern = 85Sept 2001 to Dec 2013

Neuroendocrine Tumors

Trial page ClinicalTrials.govUpdated 26 Mar 2020

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

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