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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-002349-38 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanreotide (microparticle formulation) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Universitaire St. LUC | Brussels | Belgium | ||||
| Institut Jules Bordet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23109694 | Derived | 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. |
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|
| Placebo | Other | A single intra-muscular injection on day 0. |
|
| 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 |
| Symptom relief duration | Between the first day of clinical response and the end of follow-up |
| 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 |
| ID | Term |
|---|---|
| D007415 | Intestinal Obstruction |
| D002277 | Carcinoma |
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D004067 | Digestive System Neoplasms |
| D010532 | Peritoneal Diseases |
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| ID | Term |
|---|---|
| C060347 | lanreotide |
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