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Study · Randomized controlled trial · n = 80 · 2012

6 results

Symptomatic treatment with lanreotide microparticles in inoperable bowel obstruction resulting from peritoneal carcinomatosis: a randomized, double-blind, placebo-controlled phase III study.

Mariani P, Blumberg J, Landau A, Lebrun-Jezekova D, Botton E, Beatrix O, Mayeur D, Herve R, Maisonobe P, Chauvenet L

Journal of clinical oncology : official journal of the American Society of Clinical Oncology29 Oct 2012Cited by 38 (Europe PMC)

PMID23109694 (opens in a new tab)DOI10.1200/jco.2011.40.5712 (opens in a new tab)PepBankPUB-23109694
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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.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In malignant bowel obstruction, day 7 response in the primary ITT diary analysis was 41.9% with lanreotide versus 29.7% with placebo, not statistically significant (OR 1.75, 95% CI 0.68 to 4.49, P = .24).

    In plain wordsIn malignant bowel obstruction, lanreotide did not significantly improve diary-based response versus placebo.

    Peptide
    Lanreotide
    Outcome
    No significant changeDay seven response, primary ITT diary analysis
    Study

    n = 80

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Gastrointestinal Symptoms · Gastrointestinal
    Studied dose
    30 mg, one injection · 10 daysAs given in this study (human).

    Measurements

    Response rate
    41.9%
    lanreotide, 18 of 43
    Response rate
    29.7%
    placebo, 11 of 37
    Odds ratio
    1.75 ratio
    lanreotide vs placebo
    95% CI of odds ratio
    0.68 to 4.49 ratio
    lanreotide vs placebo

    Source sentences

    Summary
    More patients receiving lanreotide than placebo were responders; this difference was not statistically significant for the intent-to-treat (ITT) population on the basis of diary cards (primary analysis; 41.9% [18 of 43] v 29.7% [11 of 37], respectively; odds ratio, 1.75; 95% CI, 0.68 to 4.49; P = .24)
    3 context sentences
    Summary · context
    The primary end point was the proportion of patients responding on day 7 (one or fewer episodes of vomiting per day or no vomiting recurrence after NGT removal [for ≥ 3 consecutive days in both cases]).
    Summary · context
    In all, 80 patients with peritoneal carcinomatosis, inoperable malignant digestive obstruction, and two or more vomiting episodes per day or nasogastric tube (NGT) who were previously treated with intravenous corticosteroids and proton pump inhibitors
    Summary · context
    were randomly assigned to one 30-mg injection of lanreotide microparticles (n = 43) or placebo (n = 37) in a 10-day, double-blind, parallel-group phase.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In malignant bowel obstruction, lanreotide and placebo did not significantly differ on the other secondary endpoints.

    In plain wordsIn malignant bowel obstruction, lanreotide did not significantly change other secondary outcomes versus placebo.

    Peptide
    Lanreotide
    Outcome
    No significant changeOther secondary endpoints
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Gastrointestinal Symptoms · Gastrointestinal
    Studied dose
    30 mg, one injection · 10 daysAs given in this study (human).

    Source sentences

    Summary
    No significant differences were observed for other secondary end points.
    3 context sentences
    Summary · context
    Vomiting frequency/NGT secretion volumes, nausea, abdominal pain, well-being, and safety were also assessed.
    Summary · context
    In all, 80 patients with peritoneal carcinomatosis, inoperable malignant digestive obstruction, and two or more vomiting episodes per day or nasogastric tube (NGT) who were previously treated with intravenous corticosteroids and proton pump inhibitors
    Summary · context
    were randomly assigned to one 30-mg injection of lanreotide microparticles (n = 43) or placebo (n = 37) in a 10-day, double-blind, parallel-group phase.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In malignant bowel obstruction, investigator-assessed response was 50.0% with lanreotide versus 28.6% with placebo, P < .05.

    In plain wordsIn malignant bowel obstruction, lanreotide improved investigator-assessed response versus placebo.

    Peptide
    Lanreotide
    Outcome
    IncreaseResponse, investigator ITT analysis
    Study

    n = 73

    Comparator
    Placebo
    Outcome group
    Gastrointestinal Symptoms · Gastrointestinal
    Studied dose
    30 mg, one injection · 10 daysAs given in this study (human).

    Measurements

    Response rate
    50%
    lanreotide, investigator-assessed ITT, 19 of 38
    Response rate
    28.6%
    placebo, investigator-assessed ITT, 10 of 35

    Source sentences

    Summary
    and ITT analysis, on the basis of investigators' assessments (50.0% [19 of 38] v 28.6% [10 of 35]; P < .05).
    3 context sentences
    Summary · context
    The primary end point was the proportion of patients responding on day 7 (one or fewer episodes of vomiting per day or no vomiting recurrence after NGT removal [for ≥ 3 consecutive days in both cases]).
    Summary · context
    In all, 80 patients with peritoneal carcinomatosis, inoperable malignant digestive obstruction, and two or more vomiting episodes per day or nasogastric tube (NGT) who were previously treated with intravenous corticosteroids and proton pump inhibitors
    Summary · context
    were randomly assigned to one 30-mg injection of lanreotide microparticles (n = 43) or placebo (n = 37) in a 10-day, double-blind, parallel-group phase.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In malignant bowel obstruction, per protocol response was 57.7% with lanreotide versus 30.4% with placebo, P < .05.

    In plain wordsIn malignant bowel obstruction, lanreotide improved response versus placebo in the per protocol analysis.

    Peptide
    Lanreotide
    Outcome
    IncreaseResponse, per protocol diary analysis
    Study

    n = 49

    Comparator
    Placebo
    Outcome group
    Gastrointestinal Symptoms · Gastrointestinal
    Studied dose
    30 mg, one injection · 10 daysAs given in this study (human).

    Measurements

    Response rate
    57.7%
    lanreotide, per protocol, 15 of 26
    Response rate
    30.4%
    placebo, per protocol, 7 of 23

    Source sentences

    Summary
    but was statistically significant for the corresponding supportive per protocol analysis (57.7% [15 of 26] v 30.4% [seven of 23]; P < .05)
    3 context sentences
    Summary · context
    The primary end point was the proportion of patients responding on day 7 (one or fewer episodes of vomiting per day or no vomiting recurrence after NGT removal [for ≥ 3 consecutive days in both cases]).
    Summary · context
    In all, 80 patients with peritoneal carcinomatosis, inoperable malignant digestive obstruction, and two or more vomiting episodes per day or nasogastric tube (NGT) who were previously treated with intravenous corticosteroids and proton pump inhibitors
    Summary · context
    were randomly assigned to one 30-mg injection of lanreotide microparticles (n = 43) or placebo (n = 37) in a 10-day, double-blind, parallel-group phase.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In malignant bowel obstruction, lanreotide improved well-being more than placebo on days 3, 6, and 7.

    In plain wordsIn malignant bowel obstruction, lanreotide improved well-being more than placebo on days 3, 6, and 7.

    Peptide
    Lanreotide
    Outcome
    IncreaseWell-being
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Quality of life · Whole body
    Studied dose
    30 mg, one injection · 10 daysAs given in this study (human).

    Source sentences

    Summary
    Improvements in well-being were significantly greater with lanreotide on days 3, 6, and 7.
    2 context sentences
    Summary · context
    In all, 80 patients with peritoneal carcinomatosis, inoperable malignant digestive obstruction, and two or more vomiting episodes per day or nasogastric tube (NGT) who were previously treated with intravenous corticosteroids and proton pump inhibitors
    Summary · context
    were randomly assigned to one 30-mg injection of lanreotide microparticles (n = 43) or placebo (n = 37) in a 10-day, double-blind, parallel-group phase.
  6. 06HumanNon-randomized trialSafety outcome

    In malignant bowel obstruction, two mild or moderate treatment-emergent adverse events were considered related to lanreotide.

    In plain wordsIn malignant bowel obstruction, two mild or moderate adverse events were considered related to lanreotide.

    Peptide
    Lanreotide
    Outcome
    Not applicableRelated treatment-emergent adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    30 mg, one injectionAs given in this study (human).

    Measurements

    Treatment-emergent adverse events considered related to lanreotide
    2 events
    mild or moderate

    Source sentences

    Summary
    Only two (mild/moderate) treatment-emergent adverse events were considered related to lanreotide.
    2 context sentences
    Summary · context
    In all, 80 patients with peritoneal carcinomatosis, inoperable malignant digestive obstruction, and two or more vomiting episodes per day or nasogastric tube (NGT) who were previously treated with intravenous corticosteroids and proton pump inhibitors
    Summary · context
    were randomly assigned to one 30-mg injection of lanreotide microparticles (n = 43) or placebo (n = 37) in a 10-day, double-blind, parallel-group phase.

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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT00216372

Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis

Ipsenn = 80Sept 2003 to Oct 2008

Intestinal Obstruction · Carcinoma · Peritoneal Neoplasms

Trial pageClinicalTrials.govUpdated 5 Nov 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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:36 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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