Clinical Trial Results:
Thromboprophylaxis in Oesophageal Cancer Patients – A Randomized, Controlled Trial
Summary
|
|
EudraCT number |
2021-001335-24 |
Trial protocol |
DK |
Global end of trial date |
01 Aug 2024
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
31 May 2025
|
First version publication date |
31 May 2025
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
141190
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Aarhus University Hospital
|
||
Sponsor organisation address |
Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark, 8200
|
||
Public contact |
Department of Clinical Biochemistry, Aarhus University Hospital, 0045 78455252, biokemi@auh.rm.dk
|
||
Scientific contact |
Department of Clinical Biochemistry, Aarhus University Hospital, 0045 78455252, biokemi@auh.rm.dk
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
01 Aug 2024
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
01 Aug 2024
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
01 Aug 2024
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
The objective of the study is to examine the efficacy and safety of prolonged thromboprophylactic treatment with Fragmin® in oesophageal cancer patients undergoing intended curative surgery.
|
||
Protection of trial subjects |
Monitoring of side effects to study drug
|
||
Background therapy |
All patients underwent intended curative surgery for oesophageal cancer. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 2021
|
||
Long term follow-up planned |
Yes
|
||
Long term follow-up rationale |
Scientific research | ||
Long term follow-up duration |
1 Years | ||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Denmark: 94
|
||
Worldwide total number of subjects |
94
|
||
EEA total number of subjects |
94
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
35
|
||
From 65 to 84 years |
59
|
||
85 years and over |
0
|
|
|||||||||||||||||||
Recruitment
|
|||||||||||||||||||
Recruitment details |
Patients were included between September 2021 and April 2024. Adult patients with esophageal adenocarcinomas or squamous cell carcinomas referred for intended curative esophagectomy at Aarhus University Hospital, Denmark, were included. | ||||||||||||||||||
Pre-assignment
|
|||||||||||||||||||
Screening details |
152 patients screened and of this 58 were not eligible due to: Cancelled surgery (n=6), logistics (n=12), ongoing anticoagulant treatment (n=28), declined to participate (n=9), not oesophageal cancer (n=2), inherited bleeding disorder (n=1) | ||||||||||||||||||
Period 1
|
|||||||||||||||||||
Period 1 title |
Overall trial (overall period)
|
||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||
Blinding used |
Not blinded | ||||||||||||||||||
Arms
|
|||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||
Arm title
|
Standard treatment | ||||||||||||||||||
Arm description |
The standard group received prophylaxis with 5000 IU Fragmin (dalteparin, Pfizer ApS) for the duration of admittance to the hospital after esophagectomy, usually 10 days according to the local standard of care. | ||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
|
||||||||||||||||||
Arm title
|
Intervention arm | ||||||||||||||||||
Arm description |
The intervention group received prophylaxis with 5000 IU Fragmin (dalteparin, Pfizer ApS) for 30 days. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Fragmin®
|
||||||||||||||||||
Investigational medicinal product code |
00069-0196-01
|
||||||||||||||||||
Other name |
Dalteparin
|
||||||||||||||||||
Pharmaceutical forms |
Anticoagulant and preservative solution for blood
|
||||||||||||||||||
Routes of administration |
Solution for injection
|
||||||||||||||||||
Dosage and administration details |
5,000 IU solution for injection in prefilled syringes
|
||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Standard treatment
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
The standard group received prophylaxis with 5000 IU Fragmin (dalteparin, Pfizer ApS) for the duration of admittance to the hospital after esophagectomy, usually 10 days according to the local standard of care. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Intervention arm
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
The intervention group received prophylaxis with 5000 IU Fragmin (dalteparin, Pfizer ApS) for 30 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Standard treatment
|
||
Reporting group description |
The standard group received prophylaxis with 5000 IU Fragmin (dalteparin, Pfizer ApS) for the duration of admittance to the hospital after esophagectomy, usually 10 days according to the local standard of care. | ||
Reporting group title |
Intervention arm
|
||
Reporting group description |
The intervention group received prophylaxis with 5000 IU Fragmin (dalteparin, Pfizer ApS) for 30 days. |
|
|||||||||||||
End point title |
Levels of prothrombin fragment 1+2 | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Measured one month after surgery
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Primary endpoint analysis | ||||||||||||
Statistical analysis description |
Difference in prothrombin fragment 1 + 2 levels in the 2 groups 1 month after surgery as an intention-to-treat analysis
|
||||||||||||
Comparison groups |
Standard treatment v Intervention arm
|
||||||||||||
Number of subjects included in analysis |
79
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.41 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From inclusion to one month after surgery.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
SNOMED CT | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
2025-03-31
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Standard treatment
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
The standard group received prophylaxis with 5000 IU Fragmin (dalteparin, Pfizer ApS) for the duration of admittance to the hospital after esophagectomy, usually 10 days according to the local standard of care. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Intervention arm
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
The intervention group received prophylaxis with 5000 IU Fragmin (dalteparin, Pfizer ApS) for 30 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Risk of type II error due to low accrual | |||
Online references |
|||
http://www.ncbi.nlm.nih.gov/pubmed/39242497 http://www.ncbi.nlm.nih.gov/pubmed/39842514 http://www.ncbi.nlm.nih.gov/pubmed/40095681 |