Primary objective:The primary objective of this study is to assess the efficacy of lanreotide 30 mg as compared to placebo to relieve clinical symptoms due to small bowel obstruction in inoperable patients with peritoneal carcinomatosis.Secondary…
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary efficacy criteria:
Pecentage of responder patients at D7.
A responder patient will be defined either as a patient experiencing one or
less vomiting episode per day during at least three consecutive days or as a
patient in whom NGT has been removed during at least three consecutive days
without vomiting recurrence.
Secondary outcome
Secondary criteria:
Efficacy criteria
- Number of daily vomiting episodes recorded in the diary cards or measurement
of the daily drainage by NGT
- Number of days with no vomiting episodes
- Number of daily nausea episodes recorded on diary cards
- intensity of abdominal pain assessed on a visual analogue scale
- Well-being assessed on a visual analogue scale
- Time between first injection (inclusion) and clinical response
- Symptom relief duration
- Symtomatic concomitant treatment consumption
- Hospitalisation duration
Safety criteria
- Clinical and biological adverse events
Background summary
Previous studies have shown that vomiting and pain due to bowel obstruction
could be controlled by somatostatin analogues administered daily by
subcutaneous injections in patients unresponsive to conventional therapy.
Considering that a prolonged release of somatostatin analogues is as effective
and more convenient for clinical use than discontinued injections, it has been
decided to evaluate, by a placebo - controlled, randomised study, the efficacy
of one intra-muscular injection of lanreotide 30 mg in the managment of
symptoms secondary to inoperable intestinal obstruction in terminal cancer
patients.
Study objective
Primary objective:
The primary objective of this study is to assess the efficacy of lanreotide 30
mg as compared to placebo to relieve clinical symptoms due to small bowel
obstruction in inoperable patients with peritoneal carcinomatosis.
Secondary objectives:
To assess the efficacy of lanreotide 30mg as compared to placebo in terms of:
- vomiting improvement or decrease in the secretion volume sucked up by a
nasogastric tube
- nausea improvement
- pain improvement
- well-being improvement
- symptom improvement delay
- symptom improvement duration
- concomitant medications consumption
- hospitalisation duration
To assess the clinical and biological safety of treatment.
Study design
- Blinded phase: this phase will be a randomised, double-blind, comparative,
placebo controlled phase carried out on 2 parallel groups
- Open phase: this phase will be a non randomised one. According to
investigator's and patient's decision at the end of the blinded phase, patients
will receive (or not) injections of open-labelled lanreotide every 10 days.
Patients will be eligible to enter the open phase only upon completion of the
blinded phase.
Intervention
Not applicable
Study burden and risks
The risk associated with participation in the study are those associated with
the administration of lanreotide 30mg. None of the procedures being performed
during this study are additional to the treatment that would otherwise be
employed.
The drug risks are digestive disorders (diarrhoea, constipation, abdominal
pain) and transient pain at the administration site.
Considering that lanreotide 30mg may modify insulin and glucagon secretion,
changes in glycaemic balance could occur.
Due to antisecretory properties, lanreotide 30mg is expected to relief clinical
symptoms (e.g. vomiting, nausea, pain) associated to bowel obstruction and thus
also to shorten the hospitalisation duration.
Guldensporenpark 87
9820 Merelbeke
Belgium
Guldensporenpark 87
9820 Merelbeke
Belgium
Listed location countries
Age
Inclusion criteria
- Patient having given written (personally signed and dated) informed consent before completing any study related procedure,
- Patient being over 18 years of age
- Patient having a high digestive obstruction i.e. located on the upper part of the gastro-intestinal tract (stomach, duodenum, small bowel)
- Patient having a digestive obstruction of malignant origin.
- Patient having a peritoneal carcinomatosis confirmed by a CT Scan within the previous 3 months
- Patient having an obstruction with at least two vomiting episodes per day or the presence of a nasogastric suction tube
- Patient for whom surgery is inappropriate, either documented in the medical records or confirmed by a surgical advice within the previous 72 hours
- Patients being treated by intra-venous corticoids since at least 5 days and intravenous proton pump inhibitors
- Patients having an estimated survival of more than one month
- Patients accepting to comply fully with the protocol.
Exclusion criteria
- Patient having an operable obstruction
- Patient having a colic obstruction (must be documented by an abdominal X-Ray within the previous 3 days)
- Patient having received any specific anticancer therapy within the previous 15 days
- Patient receiving any antiH2 receptor blockers
- Patient having a bowel obstruction which could be explained by a non malignant cause (e.g. hypokaliaemia, drug side-effects, renal insufficiency)
- Patient having signs of bowel perforation
- Patient having received somatostatin or any analogue as treatment of the bowel obstruction
- Patient having a contraindication to intra-muscular injections
- Patient having a known hypersensitivity to any of the test materials or related compounds
- Patient having previously entered this study
- Patient having been included in another clinical study within the previous 30 days.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2005-002349-38-NL |
| CCMO | NL15623.018.06 |