Trial · Interventional
TerminatedPhase 2Registry dataPasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis
Short name PASIREOCHIP
This trial was stopped early.
Reason given at the registry: No more experimental drugs available
Overview
- Status
- Terminated
- Phase
- Phase 2
- Enrollment
- 6 participants (actual)
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris · Other
- Design
- Randomized · Single masking
- Countries
1 country
France
- Start
- 3 Sept 2020
- Primary completion
- 7 Feb 2024
- Completion
- 7 Feb 2024
- First posted
- 1 Apr 2021
- Last update posted
- 8 Feb 2024
- Conditions
- Peritoneal Carcinomatosis
Timeline
1 trial · 1 stopped early
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
To assess the efficacy of pasireotide in the reduction of clinically relevant postoperative digestive leakage after CRS plus HIPEC compared to placebo
Interventions
- Pasireotide 0.9 MG/MLDrug
- Saline waterOther
Arms2
Experimental
Pasireotide
0.9 mg of pasireotide subcutaneously (s.c.) twice daily (14 doses) every 12 +/- 2 hours
Placebo comparator
Placebo
0.9 ml of saline water s.c. twice daily (14 doses) every 12 +/- 2 hours
Primary outcomes1
Outcomes the sponsor listed as primary.
postoperative digestive leakage
Time frame · 97 days
Registry description
The rate of clinically relevant (NCI CTCAE v5 ≥ grade 3) postoperative digestive leakage at 97 days
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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