Clinical Trial Results:
Feasibility and efficacy of adjuvant gemcitabine chemotherapy after liver transplantation for proximal bile duct cancer
|
Summary
|
|
EudraCT number |
2010-020480-21 |
Trial protocol |
DE |
Global end of trial date |
21 Apr 2021
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
16 Jul 2022
|
First version publication date |
16 Jul 2022
|
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 |
pro-duct001
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Charité – Universitätsmedizin Berlin
|
||
Sponsor organisation address |
Charité Platz 1, Berlin, Germany, 10117
|
||
Public contact |
Prof. Dr. Johann Pratschke, Chirurgische Klinik, Campus Virchow-Klinikum, Augustenburger Platz , 13353 Berlin., 030 450 552001, moritz.schmelzle@charite.de
|
||
Scientific contact |
Prof. Dr. Moritz Schmelzle, Chirurgische Klinik Poliklinik, 030 450 652336, moritz.schmelzle@charite.de
|
||
|
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 |
Interim
|
||
Date of interim/final analysis |
21 Apr 2021
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
21 Apr 2021
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
21 Apr 2021
|
||
Was the trial ended prematurely? |
Yes
|
||
|
General information about the trial
|
|||
Main objective of the trial |
To investigate, if adjuvant gemcitabine chemotherapy is feasible in ≥ 85 % of patients after liver transplantation.
|
||
Protection of trial subjects |
Depending on the postoperative course, the adjuvant chemotherapy is intended to start 4 to 8 weeks after liver transplantation, but not later than at the end of the 10th week after transplantation. If patients are unable to be randomized until 10 weeks after liver transplantation, they will be excluded from the study and not included in the per-protocol analysis. Toxicities are graded according to the World Health Organization (WHO).
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Jul 2010
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Germany: 6
|
||
Worldwide total number of subjects |
6
|
||
EEA total number of subjects |
6
|
||
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) |
6
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
||||||||||
|
Recruitment
|
||||||||||
Recruitment details |
From July 2012 to September 2016, 12 patients from four German transplant centers. | |||||||||
|
Pre-assignment
|
||||||||||
Screening details |
to be assessed for eligibility. n = 150 to be listed for transplantation: n = 80 to undergo liver transplantation: n = 60 to be randomized (allocated to trial: adjuvant therapy versus obersvation): n = 45 | |||||||||
|
Period 1
|
||||||||||
Period 1 title |
Baseline and trial period (overall period)
|
|||||||||
Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Not blinded | |||||||||
Blinding implementation details |
6 participants were recruited to the study. No final analysis was done as the trial was terminated early due to difficulties in recruitment.
|
|||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
Experimental Group | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Gemcitabine
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Powder for infusion
|
|||||||||
Routes of administration |
Infusion
|
|||||||||
Dosage and administration details |
800 mg/m² in cycles 1 and . if tolerated the dosage cycles 3 to 6 is increased to 1000 mg/m² per application
|
|||||||||
|
Arm title
|
Control group | |||||||||
Arm description |
Patients in the control group receive no adjuvant treatment, which represents the standard medical treamtnet for bile duct cancers. | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
|
|||||||||
|
||||||||||
|
|||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Experimental Group
|
||
Reporting group description |
- | ||
Reporting group title |
Control group
|
||
Reporting group description |
Patients in the control group receive no adjuvant treatment, which represents the standard medical treamtnet for bile duct cancers. | ||
|
|||||||||||||
End point title |
Final Endpoint [1] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Only 6 participants were recruited to the study, no analysis was carried out. Trial was terminated early due to problems with recruitment.
|
||||||||||||
| 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: Only 6 participants were recruited to the study, no analysis was carried out. Trial was terminated early due to problens with recruitment |
|||||||||||||
|
|||||||||||||
| Notes [2] - Only 6 participants were recruited to the study, no analysis was carried out. Trial was terminated e [3] - Only 6 participants were recruited to the study, no analysis was carried out. Trial was terminated e |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||
|
Adverse events information [1]
|
|||
Timeframe for reporting adverse events |
12 months after liver transpantations
|
||
Assessment type |
Systematic | ||
|
Dictionary used for adverse event reporting
|
|||
Dictionary name |
own | ||
Dictionary version |
1
|
||
| 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: no AEs and SAEs were reported and due to premature ending. |
|||
|
|||
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. | |||
| -Recruitment difficulties -terminated prematurely -no final conclusion -constellation necessary for liver transplantation is very rarely in PHC - | |||
