Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis
NCT ID: NCT00216372
Last Updated: 2020-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
80 participants
INTERVENTIONAL
2003-09-30
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Lanreotide (microparticle formulation)
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.
2
Placebo
A single intra-muscular injection on day 0.
Interventions
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Lanreotide (microparticle formulation)
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.
Placebo
A single intra-muscular injection on day 0.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* signs of bowel perforation
* somatostatin or any analogue as treatment of the bowel obstruction
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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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, , France
Hôpital Saint André
Bordeaux, , France
Hôpital de la Cavale Blanche
Brest, , France
Centre François Baclesse
Caen, , France
Hôpital Nord
Cébazat, , France
Clinique de l'Amandier
Châtenay-Malabry, , France
Hôpital Hôtel-Dieu
Clermont-Ferrand, , France
Hôpital Beaujon
Clichy, , France
Hôpital Pasteur
Colmar, , France
Centre Hospitalier de Compiègne
Compiègne, , France
Hôpital Henri Mondor
Créteil, , France
Centre Hospitalier Victor Jousselin
Dreux, , France
Clinique Sainte Marguerite
Hyères, , France
Centre Hospitalier Départemental
La Roche-sur-Yon, , France
Hôpital André Mignot
Le Chesnay, , France
Hôpital Notre-Dame du Perpétuel Secours
Levallois-Perret, , France
CHU Dupuytren
Limoges, , 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, , France
Institue Curie
Paris, , France
Hôpital des Diaconesses
Paris, , France
Hôpital Saint Antoine
Paris, , France
Hôtel Dieu
Paris, , France
Hôpital Pitié Salpêtrière
Paris, , France
Hôpital Georges Pompidou
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Institut Jean Godinot
Reims, , France
Centre Eugène Marquis
Rennes, , France
Centre Hospitalier de Roanne
Roanne, , France
CAC Becquerel
Rouen, , France
Hôpital Charles Nicolle
Rouen, , France
Clinique Armoricaine de Radiologie
Saint-Brieuc, , France
Clinique Guillaume de Varye
Saint-Doulchard, , France
Institut de Cancérologie de la Loire
Saint-Etienne, , France
Centre Hospitalier Gaston Ramon
Sens, , France
Hôpital Civil
Strasbourg, , France
Hôpital Hautepierre
Strasbourg, , France
C.H.R. de Metz-Thionville
Thionville, , France
Hôpital de Rangueil
Toulouse, , France
Hôpital Joseph Ducuing
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Academisch Medisch Centrum
Amsterdam, , Netherlands
Countries
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References
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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.
Other Identifiers
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2005-002349-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2-54-52030-156 (408)
Identifier Type: -
Identifier Source: org_study_id