Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis
Phase III, Multicentre, Randomised, Double-blind, Comparative Study to Assess the Efficacy and Safety of Lanreotide 30 mg Versus Placebo as a Palliative Treatment of Clinical Symptoms Associated With Intestinal Obstruction Due to Peritoneal Carcinomatosis in Inoperable Patients.
2 other identifiers
interventional
80
3 countries
53
Brief Summary
The purpose of this study is to determine whether lanreotide 30mg microparticles are effective in the relief of clinical symptoms due to small bowel obstruction in inoperable patients with peritoneal carcinomatosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2003
Longer than P75 for phase_3
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedNovember 5, 2020
November 1, 2020
5.1 years
September 13, 2005
November 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of responder patients (patient with 1 or less vomiting episode per day during at least 3 consecutive days or in whom nasogastric tube (NGT) has been removed during at least three consecutive days without vomiting recurrence)
On day 7 (plus 1 day at the latest) after the first injection
Secondary Outcomes (6)
Number of daily vomiting episodes or measurement of the daily drainage by NGT
Daily for the duration of the study
Number of days with no vomiting episodes
For the duration of the study
Number of daily nausea episodes
Daily for the duration of the study
Intensity of abdominal pain
Daily for the duration of the study
Well-being
Daily for the duration of the study
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
A single 30 mg intra-muscular injection on day 0. The duration of the blinded phase is 10 days. Patients may enter the open phase where they receive 30 mg intra-muscular injections, every 10 days until investigator/or patient decide to stop treatment.
Eligibility Criteria
You may qualify if:
- digestive obstruction located in the upper part of the gastro-intestinal tract
- digestive obstruction of malignant origin
- peritoneal carcinomatosis confirmed by a CT Scan
- at least two vomiting episodes per day or a presence of a nasogastric suction tube
- inoperable patients
You may not qualify if:
- specific anticancer therapy within the previous 15 days
- signs of bowel perforation
- somatostatin or any analogue as treatment of the bowel obstruction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (53)
Clinique Universitaire St. LUC
Brussels, Belgium
Institut Jules Bordet
Brussels, Belgium
Clinique Notre-Dame
Hermalle-sous-Huy, Belgium
Centre Hospitalier de Jolimont-Lobbes
La Louvière, Belgium
Hôpital Nord
Amiens, France
Clinique de l'Anjou
Angers, France
Hôtel-Dieu
Angers, France
CH Victor Dupouy
Argenteuil, 95100, France
Hôpital Saint André
Bordeaux, 33075, France
Hôpital de la Cavale Blanche
Brest, 29609, France
Centre François Baclesse
Caen, France
Hôpital Nord
Cébazat, 63118, France
Clinique de l'Amandier
Châtenay-Malabry, France
Hôpital Hôtel-Dieu
Clermont-Ferrand, France
Hôpital Beaujon
Clichy, 92118, France
Hôpital Pasteur
Colmar, France
Centre Hospitalier de Compiègne
Compiègne, 60321, France
Hôpital Henri Mondor
Créteil, 94000, France
Centre Hospitalier Victor Jousselin
Dreux, 28102, France
Clinique Sainte Marguerite
Hyères, France
Centre Hospitalier Départemental
La Roche-sur-Yon, France
Hôpital André Mignot
Le Chesnay, 78150, France
Hôpital Notre-Dame du Perpétuel Secours
Levallois-Perret, 92309, France
CHU Dupuytren
Limoges, 87042, France
Hôpital Site de Lorient
Lorient, France
Hôpital de la Croix Rousse
Lyon, France
Hôpital de l'Archet 2
Nice, France
Hôpital de la Source
Orléans, France
Centre de Radiothérapie et Oncologie Médicale
Osny, France
Hôpital du Val de Grâce
Paris, 75005, France
Institue Curie
Paris, 75005, France
Hôpital des Diaconesses
Paris, 75012, France
Hôpital Saint Antoine
Paris, 75012, France
Hôtel Dieu
Paris, 75181, France
Hôpital Pitié Salpêtrière
Paris, 75651, France
Hôpital Georges Pompidou
Paris, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Institut Jean Godinot
Reims, France
Centre Eugène Marquis
Rennes, France
Centre Hospitalier de Roanne
Roanne, France
CAC Becquerel
Rouen, 76038, France
Hôpital Charles Nicolle
Rouen, France
Clinique Armoricaine de Radiologie
Saint-Brieuc, 22015, France
Clinique Guillaume de Varye
Saint-Doulchard, France
Institut de Cancérologie de la Loire
Saint-Etienne, 42020, France
Centre Hospitalier Gaston Ramon
Sens, 89108, France
Hôpital Civil
Strasbourg, 67091, France
Hôpital Hautepierre
Strasbourg, France
C.H.R. de Metz-Thionville
Thionville, 57126, France
Hôpital de Rangueil
Toulouse, France
Hôpital Joseph Ducuing
Toulouse, France
Institut Gustave Roussy
Villejuif, France
Academisch Medisch Centrum
Amsterdam, Netherlands
Related Publications (1)
Mariani P, Blumberg J, Landau A, Lebrun-Jezekova D, Botton E, Beatrix O, Mayeur D, Herve R, Maisonobe P, Chauvenet L. Symptomatic treatment with lanreotide microparticles in inoperable bowel obstruction resulting from peritoneal carcinomatosis: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol. 2012 Dec 10;30(35):4337-43. doi: 10.1200/JCO.2011.40.5712. Epub 2012 Oct 29.
PMID: 23109694DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
September 1, 2003
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
November 5, 2020
Record last verified: 2020-11