Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis
Phase 3
Completed
- 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
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
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
🇧🇪Bruxelles, Belgium
Institut Jules Bordet
🇧🇪Bruxelles, Belgium
Clinique Notre-Dame
🇧🇪Hermalle-sous-Huy, Belgium
Centre Hospitalier de Jolimont-Lobbes
🇧🇪La Louvière, Belgium
Hôpital Nord
🇫🇷Cebazat, 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
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