Clinical Trial Results:
Perioperative ketorolac in high risk breast cancer patients with and without inflammation. A prospective randomized placebo-controlled trial.
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Summary
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EudraCT number |
2012-003774-76 |
Trial protocol |
BE |
Global end of trial date |
01 Sep 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Jan 2021
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First version publication date |
07 Jan 2021
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Other versions |
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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 |
1.0
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01806259 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Cliniques universitaires Saint-Luc
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Sponsor organisation address |
Avenue Hippocrate, 10, Brussels, Belgium, 1200
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Public contact |
Dpt of Anesthesiology, Cliniques universitaires Saint-Luc, forgetpatrice@yahoo.fr
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Scientific contact |
Dpt of Anesthesiology, Cliniques universitaires Saint-Luc, forgetpatrice@yahoo.fr
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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 |
01 Oct 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 |
01 Sep 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 test if the use of Ketorolac at the moment of the operative incision reduces the number of recurrence in patients with breast cancer.
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Protection of trial subjects |
This study was conducted in accordance with International Conference on Harmonisation (ICH), Good Clinical Practice (GCP) regulations/guidelines, United States Food and Drug Administration (FDA) regulations/guidelines, and country-specific national ans local laws.
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Background therapy |
Ketorolac: one dose of Ketorolac 30 mg intravenously before surgery. | ||
Evidence for comparator |
Placebo: one dose of Ketorolac of NaCL 0.9% 3ml intravenously before surgery. | ||
Actual start date of recruitment |
01 Feb 2013
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Efficacy, Safety | ||
Long term follow-up duration |
5 Years | ||
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: 203
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Worldwide total number of subjects |
203
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EEA total number of subjects |
203
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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) |
136
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From 65 to 84 years |
65
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85 years and over |
2
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Recruitment
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Recruitment details |
Between February 2013 and July 205, 203 patients from 4 sites in Belgium. | |||||||||
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Pre-assignment
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Screening details |
After written informed consent, breast cancer patients scheduled for curative surgery were randomized to receive a dose of Ketorolac or placebo prior to the surgical incision upon induction of anesthesia. | |||||||||
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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 |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
Blinding implementation details |
Randomization and blinding performed by the pharmacist in charge of preparing the product under study in each center.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Ketorolac 30 mg | |||||||||
Arm description |
Patients received one dose of 30 mg of Ketorolac slowly intravenously before the incision. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Ketorolac
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
One dose of 30 mg intravenous.
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Arm title
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Placebo | |||||||||
Arm description |
Patients received one dose of NaCL 0.9% 3 ml slowly intravenously before the incision. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Sodium Chloride
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Investigational medicinal product code |
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Other name |
Isotonic saline solution, Normal saline solution, Physiological saline solution
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
One dose of NaCL 0.9% 3 ml slowly intravenously.
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Baseline characteristics reporting groups
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Reporting group title |
Ketorolac 30 mg
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Reporting group description |
Patients received one dose of 30 mg of Ketorolac slowly intravenously before the incision. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Patients received one dose of NaCL 0.9% 3 ml slowly intravenously before the incision. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Ketorolac 30 mg
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Reporting group description |
Patients received one dose of 30 mg of Ketorolac slowly intravenously before the incision. | ||
Reporting group title |
Placebo
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Reporting group description |
Patients received one dose of NaCL 0.9% 3 ml slowly intravenously before the incision. | ||
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End point title |
Recurrence-free Survival | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
5 years
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Statistical analysis title |
Disease-free survival (DFS) | |||||||||
Comparison groups |
Ketorolac 30 mg v Placebo
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Number of subjects included in analysis |
203
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.517 | |||||||||
Method |
Logrank | |||||||||
Parameter type |
Hazard ratio (HR) | |||||||||
Point estimate |
1.23
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Confidence interval |
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95% | |||||||||
sides |
2-sided
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lower limit |
0.65 | |||||||||
upper limit |
2.31 | |||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
30 days.
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Adverse event reporting additional description |
Any type of adverse event possibly linked to the IMP.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
CTCAE Grade | |||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.03
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Reporting groups
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Reporting group title |
Ketorolac 30 mg
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Reporting group description |
Patients received one dose of 30 mg of Ketorolac slowly intravenously before the incision. | |||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Patients received one dose of NaCL 0.9% 3 ml slowly intravenously before the incision. | |||||||||||||||||||||||||||||||||||||||||||||
| 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: There were no side effects identified in the study. Serious adverse events were due to the participants' initial illness. |
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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. | |||
| None reported | |||
