Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis
- Conditions
- CarcinomaPeritoneal NeoplasmsIntestinal Obstruction
- Interventions
- Other: Placebo
- Registration Number
- NCT00216372
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- specific anticancer therapy within the previous 15 days
- signs of bowel perforation
- somatostatin or any analogue as treatment of the bowel obstruction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Lanreotide (microparticle formulation) - 2 Placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Intensity of abdominal pain Daily for the duration of the study Number of daily vomiting episodes or measurement of the daily drainage by NGT Daily for the duration of the study Number of daily nausea episodes Daily for the duration of the study Number of days with no vomiting episodes For the duration of the study Symptom relief duration Between the first day of clinical response and the end of follow-up Well-being Daily for the duration of the study
Trial Locations
- Locations (52)
Clinique Universitaire St. LUC
馃嚙馃嚜Bruxelles, Belgium
Institut Jules Bordet
馃嚙馃嚜Bruxelles, Belgium
Clinique Notre-Dame
馃嚙馃嚜Hermalle-sous-Huy, Belgium
Centre Hospitalier de Jolimont-Lobbes
馃嚙馃嚜La Louvi猫re, Belgium
H么pital Nord
馃嚝馃嚪Cebazat, France
Clinique de l'Anjou
馃嚝馃嚪Angers, France
H么tel-Dieu
馃嚝馃嚪Angers, France
CH Victor Dupouy
馃嚝馃嚪Argenteuil, France
H么pital Saint Andr茅
馃嚝馃嚪Bordeaux, France
H么pital de la Cavale Blanche
馃嚝馃嚪Brest, France
Clinique de l'Amandier
馃嚝馃嚪Chatenay-Malabry, France
Centre Fran莽ois Baclesse
馃嚝馃嚪Caen, France
H么pital H么tel-Dieu
馃嚝馃嚪Clermont-Ferrand, France
H么pital Beaujon
馃嚝馃嚪Clichy, France
H么pital Pasteur
馃嚝馃嚪Colmar, France
Centre Hospitalier de Compi猫gne
馃嚝馃嚪Compiegne, France
H么pital Henri Mondor
馃嚝馃嚪Creteil, France
Centre Hospitalier D茅partemental
馃嚝馃嚪La Roche sur Yon, France
Centre Hospitalier Victor Jousselin
馃嚝馃嚪Dreux, France
Clinique Sainte Marguerite
馃嚝馃嚪Hyeres, France
H么pital Andr茅 Mignot
馃嚝馃嚪Le Chesnay, France
H么pital Notre-Dame du Perp茅tuel Secours
馃嚝馃嚪Levallois-Perret, France
CHU Dupuytren
馃嚝馃嚪Limoges, France
H么pital Site de Lorient
馃嚝馃嚪Lorient, France
H么pital de la Croix Rousse
馃嚝馃嚪Lyon, France
H么pital de l'Archet 2
馃嚝馃嚪Nice, France
H么pital de la Source
馃嚝馃嚪Orl茅ans, France
Centre de Radioth茅rapie et Oncologie M茅dicale
馃嚝馃嚪Osny, France
Institue Curie
馃嚝馃嚪Paris, France
H么pital du Val de Gr芒ce
馃嚝馃嚪Paris, France
H么pital des Diaconesses
馃嚝馃嚪Paris, France
H么tel Dieu
馃嚝馃嚪Paris, France
H么pital Saint Antoine
馃嚝馃嚪Paris, France
H么pital Piti茅 Salp锚tri猫re
馃嚝馃嚪Paris, France
H么pital Georges Pompidou
馃嚝馃嚪Paris, France
Centre Hospitalier Lyon Sud
馃嚝馃嚪Pierre Benite, France
Institut Jean Godinot
馃嚝馃嚪Reims, France
Centre Eug猫ne Marquis
馃嚝馃嚪Rennes, France
Centre Hospitalier de Roanne
馃嚝馃嚪Roanne, France
CAC Becquerel
馃嚝馃嚪Rouen, France
H么pital Charles Nicolle
馃嚝馃嚪Rouen, France
Institut de Canc茅rologie de la Loire
馃嚝馃嚪Saint Etienne, France
Clinique Armoricaine de Radiologie
馃嚝馃嚪Saint-Brieuc, France
Clinique Guillaume de Varye
馃嚝馃嚪Saint-Doulchard, France
Centre Hospitalier Gaston Ramon
馃嚝馃嚪Sens, France
H么pital Civil
馃嚝馃嚪Strasbourg, France
H么pital Hautepierre
馃嚝馃嚪Strasbourg, France
C.H.R. de Metz-Thionville
馃嚝馃嚪Thionville, France
H么pital de Rangueil
馃嚝馃嚪Toulouse, France
H么pital Joseph Ducuing
馃嚝馃嚪Toulouse, France
Institut Gustave Roussy
馃嚝馃嚪Villejuif, France
Academisch Medisch Centrum
馃嚦馃嚤Amsterdam, Netherlands