Carcinoma Clinical Trial
Official title:
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.
Verified date | November 2020 |
Source | Ipsen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | October 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - specific anticancer therapy within the previous 15 days - signs of bowel perforation - somatostatin or any analogue as treatment of the bowel obstruction |
Country | Name | City | State |
---|---|---|---|
Belgium | Clinique Universitaire St. LUC | Bruxelles | |
Belgium | Institut Jules Bordet | Bruxelles | |
Belgium | Clinique Notre-Dame | Hermalle-sous-Huy | |
Belgium | Centre Hospitalier de Jolimont-Lobbes | La Louvière | |
France | 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 | Cebazat | |
France | Clinique de l'Amandier | Chatenay-Malabry | |
France | Hôpital Hôtel-Dieu | Clermont-Ferrand | |
France | Hôpital Beaujon | Clichy | |
France | Hôpital Pasteur | Colmar | |
France | Centre Hospitalier de Compiègne | Compiegne | |
France | Hôpital Henri Mondor | Creteil | |
France | Centre Hospitalier Victor Jousselin | Dreux | |
France | Clinique Sainte Marguerite | Hyeres | |
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 des Diaconesses | Paris | |
France | Hôpital du Val de Grâce | Paris | |
France | Hôpital Georges Pompidou | Paris | |
France | Hôpital Pitié Salpêtrière | Paris | |
France | Hôpital Saint Antoine | Paris | |
France | Hôtel Dieu | Paris | |
France | Institue Curie | Paris | |
France | Centre Hospitalier Lyon Sud | Pierre Benite | |
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 | Institut de Cancérologie de la Loire | Saint Etienne | |
France | Clinique Armoricaine de Radiologie | Saint-Brieuc | |
France | Clinique Guillaume de Varye | Saint-Doulchard | |
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 | |
Netherlands | Academisch Medisch Centrum | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
Ipsen |
Belgium, France, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of daily vomiting episodes or measurement of the daily drainage by NGT | Daily for the duration of the study | ||
Secondary | Number of days with no vomiting episodes | For the duration of the study | ||
Secondary | Number of daily nausea episodes | Daily for the duration of the study | ||
Secondary | Intensity of abdominal pain | Daily for the duration of the study | ||
Secondary | Well-being | Daily for the duration of the study | ||
Secondary | Symptom relief duration | Between the first day of clinical response and the end of follow-up |
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