Clinical Trial Results:
Intraoperative intraperitoneal chemoperfusion to treat peritoneal minimal residual disease in stage III ovarian cancer: a randomized phase II trial.
Summary
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EudraCT number |
2015-000418-23 |
Trial protocol |
BE |
Global end of trial date |
25 Aug 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Jun 2024
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First version publication date |
06 Jun 2024
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Other versions |
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Summary report(s) |
Final Study Report Protocol ClinicalTrials.gov Summary attachment |
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/2015/002
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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 |
UZ Ghent
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Sponsor organisation address |
C. Heymanslaan 10, Gent, Belgium, 9000
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Public contact |
Bimetra Clinics, Ghent University Hospital, +32 93320500, bimetra.clinics@uzgent.be
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Scientific contact |
Bimetra Clinics, Ghent University Hospital, +32 93320500, bimetra.clinics@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 |
25 Aug 2021
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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 |
25 Aug 2021
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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 study the effect of cytoreductive surgery (CRS) and efficacy of cisplatin-based intraoperative intraperitoneal chemoperfusion (IPEC) in patients with primary or recurrent serous epithelial ovarian cancer (OC), in order to treat peritoneal minimal residual disease (pMRD).
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Protection of trial subjects |
See attachment Final Status Report
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Mar 2016
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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: 56
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Worldwide total number of subjects |
56
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EEA total number of subjects |
56
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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) |
56
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
See attachement Final Study Report | |||||||||||||||
Pre-assignment
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Screening details |
See attachement Final Study Report | |||||||||||||||
Period 1
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Period 1 title |
Period (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind [1] | |||||||||||||||
Roles blinded |
Subject, Data analyst, Carer, Assessor | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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low dose, normothermic | |||||||||||||||
Arm description |
CRS + normothermic (37°C) intraoperative intraperitoneal chemoperfusion, with 100mg/m² Cisplatin during 90min + adjuvant chemotherapy | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
IPEC with Cisplatin (75mg/m²)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for intravesical solution
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Routes of administration |
Other use
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Dosage and administration details |
See attachements
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Arm title
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high dose, normothermic | |||||||||||||||
Arm description |
CRS + normothermic (37°C) intraoperative intraperitoneal chemoperfusion, with 75mg/m² Cisplatin during 90min + adjuvant chemotherapy | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
IPEC with Cisplatin (100mg/m²)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection/infusion
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Routes of administration |
Other use
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Dosage and administration details |
Intraperitoneal normotherm (37°C) administration of Cisplatin (100mg/m²), during 90min
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Arm title
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low dose, hyperthermic | |||||||||||||||
Arm description |
CRS + hyperthermic (41°C) intraoperative intraperitoneal chemoperfusion, with 75mg/m² Cisplatin during 90min + adjuvant chemotherapy | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Hypertherm IntraPEritoneal Chemotherapy with Cisplatin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Other use
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Dosage and administration details |
Intraperitoneal hypertherm (41°C) administration of Cisplatin (75mg/m²), during 90min
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Arm title
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high dose, hyperthermic | |||||||||||||||
Arm description |
CRS + hyperthermic (41°C) intraoperative intraperitoneal chemoperfusion, with 100mg/m² Cisplatin during 90min + adjuvant chemotherapy | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
HIPEC with Cisplatin (100mg/m²)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Other use
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Dosage and administration details |
Intraperitoneal hypertherm (41°C) administration of Cisplatin (100mg/m²), during 90min
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Notes [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial. Justification: zie attachments |
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Notes [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: see attachments |
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End points reporting groups
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Reporting group title |
low dose, normothermic
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Reporting group description |
CRS + normothermic (37°C) intraoperative intraperitoneal chemoperfusion, with 100mg/m² Cisplatin during 90min + adjuvant chemotherapy | ||
Reporting group title |
high dose, normothermic
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Reporting group description |
CRS + normothermic (37°C) intraoperative intraperitoneal chemoperfusion, with 75mg/m² Cisplatin during 90min + adjuvant chemotherapy | ||
Reporting group title |
low dose, hyperthermic
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Reporting group description |
CRS + hyperthermic (41°C) intraoperative intraperitoneal chemoperfusion, with 75mg/m² Cisplatin during 90min + adjuvant chemotherapy | ||
Reporting group title |
high dose, hyperthermic
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Reporting group description |
CRS + hyperthermic (41°C) intraoperative intraperitoneal chemoperfusion, with 100mg/m² Cisplatin during 90min + adjuvant chemotherapy |
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End point title |
Primary [1] | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
1 tumor nodule will be immediately fixed in liquid nitrogen after cytoreductive surgery and chemoperfusion. Frozen sections will be ablated through study completion
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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: See attachments |
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No statistical analyses for this end point |
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End point title |
Secondary | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Surgical morbidity and mortality will be measured using Dindo-Clavien classification
This will be estimated with the Dindo-Clavien classification
[Time Frame: Within 30 days after surgery and intraoperative intraperitoneal chemoperfusion]
Cancer-spec
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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 |
During the study
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
0
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Frequency threshold for reporting non-serious adverse events: 5% | |||
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: See attachments |
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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. | |||
None reported |