Clinical Trial Results:
Clinical trial with chemotherapy for patients with non-resectable, locally advanced pancreatic cancer and addition of chemo-radiotherapy for patients with borderline resectable pancreatic cancer.
DPSG - ”Danish Pancreatic cancer Study Group”
Summary
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EudraCT number |
2011-000703-40 |
Trial protocol |
DK |
Global end of trial date |
15 Feb 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Jun 2021
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First version publication date |
25 Jun 2021
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Other versions |
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Summary report(s) |
Poster ASCO 2015 |
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 |
KFE10.08
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01397019 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Odense University Hospital
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Sponsor organisation address |
sdr. Boulevard 29, Odense, Denmark, 5000
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Public contact |
Research Secretary, Odense University Hospital, +45 65412921, mette.sander@rsyd.dk
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Scientific contact |
Research Secretary, Odense University Hospital, +45 65412921, mette.sander@rsyd.dk
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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 |
Interim
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Date of interim/final analysis |
01 Jan 2016
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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 |
15 Feb 2016
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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 |
The objective of the trial is to evaluate the effect of FOLFIRINOX in combination with chemo-radiotherapy in patients with borderline resectable pancreatic cancer (stage II or III).
Primary objective:
- 2 year survival
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Protection of trial subjects |
The following measures were repeatedly assessed throughout the course of the study to monitor subject safety:
(1) Assessment of adverse events and serious adverse events,
(2) clinical laboratory tests,
(3) medical history,
(4) full review of body system through physical examination,
(5) vital signs assessment,
(6) Effect of chemotherapy
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
16 May 2011
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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 |
Denmark: 53
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Worldwide total number of subjects |
53
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EEA total number of subjects |
53
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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) |
24
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From 65 to 84 years |
29
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients were recruited between 06-08-2012 to 15-02-2016. Due logistical challenges data presented is on 53 patients. Remaining patients - will be incluided in the final publication | ||||||
Pre-assignment
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Screening details |
- | ||||||
Pre-assignment period milestones
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Number of subjects started |
53 | ||||||
Number of subjects completed |
53 | ||||||
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 |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
Not blinded
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Arms
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Arm title
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Treatment | ||||||
Arm description |
Per-protocol therapy | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
FORFIRINOX
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2, 5FU 400 mg/m2+ 2400 mg/m2) every 14 days
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End points reporting groups
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Reporting group title |
Treatment
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Reporting group description |
Per-protocol therapy |
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End point title |
two-year survivial [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
data was calculated 1-jan-2016
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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: Please see attached poster for results and statistical analyses. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Evaluated during therapy/on protocol
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4
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Reporting groups
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Reporting group title |
Treatment
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Reporting group description |
Per-protocol therapy | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |