Clinical Trial Results:
Catheter based adjuvant intraperitoneal chemotherapy for carcinomatosis.
Summary
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EudraCT number |
2014-000882-34 |
Trial protocol |
BE |
Global end of trial date |
12 Nov 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Jul 2021
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First version publication date |
28 Jul 2021
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Other versions |
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Summary report(s) |
Summary |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
AGO/2014/002
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Ghent University Hospital
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Sponsor organisation address |
Corneel Heymanslaan 10, Ghent, Belgium, 9000
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Public contact |
Hiruz CTU, University Hospital Ghent, +32 93320500, hiruz.ctu@uzgent.be
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Scientific contact |
Hiruz CTU, University Hospital Ghent, +32 93320500, hiruz.ctu@uzgent.be
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 Nov 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Nov 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the feasibility and safety of adjuvant, catheter based intraperitoneal chemotherapy in patients with minimal residual disease after cytoreductive surgery for carcinomatosis from GI origin.
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Protection of trial subjects |
Ethics review and approval, informed consent, supportive care and routine monitoring.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Jun 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 2
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Worldwide total number of subjects |
2
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EEA total number of subjects |
2
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
1
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
2 patients were screened from 05-06-2014 till 12-11-2015. 2 patients were enrolled and randomised. 0 patients were included and completed the trial. End of trial notification was dated 12-11-2015 (last patient last visit) and submitted to EC and CA 12/12/2017. | ||||||||||||||||||
Pre-assignment
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Screening details |
INCLUSION CRITERIA: Peritoneal carcinomatosis from GI origin (appendix, colon, small bowel, stomach) - Resectable disease - No or minimal systemic or extra-abdominal disease or metastatic spread - Written informed consent | ||||||||||||||||||
Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
No
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Arm title
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Baseline | ||||||||||||||||||
Arm description |
Baseline data for the study, as the study only has 1 arm. | ||||||||||||||||||
Arm type |
Baseline arm | ||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Treatment | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
5-fluorouracil
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Investigational medicinal product code |
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Other name |
Fluracedyl
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intraperitoneal use
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Dosage and administration details |
5-fluorouracil 600 mg/m2 biweekly, total of 9 cycles
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Baseline
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Reporting group description |
Baseline data for the study, as the study only has 1 arm. | ||
Reporting group title |
Treatment
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Reporting group description |
- |
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End point title |
termination of IP chemotherapy due to complications or adverse events. [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Until end oif treatment due to complications or adverse events
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis available. |
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Notes [2] - Baseline arm. [3] - Drop-out of patients. |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Overall study.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24
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Reporting groups
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Reporting group title |
Baseline
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Reporting group description |
Baseline data for the study, as the study only has 1 arm. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment
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Reporting group description |
Treatment arm that received 5-fluorouracil (Fluracedyl) 600 mg/m2 intraperitoneal. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse events were recorded for the participating patients. |
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
2 patients prematurely discontinued. Only 2 patients were included because the potential number of suitable candidates that could be a candidate for this therapy was overestimated. |