Clinical Trial Results:
A treatment strategy of the Use of 1st line Chemotherapy in Patients with Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors based on tumor marker decline: A Phase II Trial of paclitaxel, ifosfamid and cisplatin regimen
|
Summary
|
|
EudraCT number |
2014-001270-33 |
Trial protocol |
SK |
Global end of trial date |
01 Jun 2021
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
13 Aug 2022
|
First version publication date |
13 Aug 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 |
GCTSK003
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT02414685 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Národný onkologický ústav
|
||
Sponsor organisation address |
Klenova 1, Bratislava, Slovakia, 833 10
|
||
Public contact |
Prof Michal Mego MD, DSc,, Národný onkologický ústav, 00421 259378108, michal.mego@nou.sk
|
||
Scientific contact |
Prof Michal Mego MD, DSc,, Národný onkologický ústav, 00421 259378108, michal.mego@nou.sk
|
||
|
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 |
23 Apr 2021
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
23 Apr 2021
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
01 Jun 2021
|
||
Was the trial ended prematurely? |
Yes
|
||
|
General information about the trial
|
|||
Main objective of the trial |
To investigate the efficacy (defined as complete response rate) of TIP in the 1st line treatment of patients with poor prognosis NSGCT and an unfavorable decrease in the serum level of tumor markers after 1 cycle of the BEP regimen.
|
||
Protection of trial subjects |
All the procedures performed in study involving human participants were conducted in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual paricipants included in the study.
|
||
Background therapy |
NA | ||
Evidence for comparator |
NA | ||
Actual start date of recruitment |
14 Aug 2015
|
||
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 |
Slovakia: 20
|
||
Worldwide total number of subjects |
20
|
||
EEA total number of subjects |
20
|
||
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) |
20
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
|||||||
|
Recruitment
|
|||||||
Recruitment details |
From 18 November 2015 to 27 March 2020 , a total of 21 patients were screened into the study. One patient did not meet study eligibility criteria, 20 subjects were enrolled and receive study treatment. | ||||||
|
Pre-assignment
|
|||||||
Screening details |
Patients with Disseminated Nonseminomatous Germ Cell Tumors with a poor prognosis according to the International Germ Cell Cancer Collaboration Group classification and an unfavorable Serum Tumor Markerdecline after the first cycle of chemotherapy | ||||||
|
Pre-assignment period milestones
|
|||||||
Number of subjects started |
20 | ||||||
Number of subjects completed |
|||||||
|
Period 1
|
|||||||
Period 1 title |
Overall Study ( overall period)
|
||||||
Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
|
||||||
Blinding used |
Not blinded | ||||||
|
Arms
|
|||||||
|
Arm title
|
TIP -Paclitaxel, Ifosfamid, Cisplatin | ||||||
Arm description |
4 cycles of TIP regimen: Taxol 250 mg/ m2 iv on day 1 Ifosfamid 1,2 g/ m2/ day iv x 5 days Cisplatin 20 mg/ m2/ day iv x 5 days. One cycle of therapy consists of 21 days. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Ifosfamid
|
||||||
Investigational medicinal product code |
SUB08125MIG
|
||||||
Other name |
|||||||
Pharmaceutical forms |
Powder for solution for infusion
|
||||||
Routes of administration |
Intravenous use
|
||||||
Dosage and administration details |
1200 mg/m2 on days 1-5, every 21 days, totally for four cycles.
|
||||||
Investigational medicinal product name |
Paclitaxel
|
||||||
Investigational medicinal product code |
SUB09583MIG
|
||||||
Other name |
|||||||
Pharmaceutical forms |
Concentrate for solution for infusion
|
||||||
Routes of administration |
Intravenous use
|
||||||
Dosage and administration details |
paclitaxel 250 mg/m2 on day 1, every 21 days, totally for four cycles.
|
||||||
Investigational medicinal product name |
Cisplatin
|
||||||
Investigational medicinal product code |
SUB07483MIG
|
||||||
Other name |
|||||||
Pharmaceutical forms |
Concentrate for solution for infusion
|
||||||
Routes of administration |
Intravenous use
|
||||||
Dosage and administration details |
cisplatin 20 mg/m2 on days 1-5, every 21 days, totally for four cycles.
|
||||||
|
|||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall Study ( overall period)
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
an open-labeled, nonrandomized, single arm trial with .the treatment regimen consisted of paclitaxel 250 mg/m2 on day 1, ifosfamide 1200 mg/m2 on days 1-5, and cisplatin 20 mg/m2 on days 1-5, totally for four cycles | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Subject analysis sets
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set title |
Overall study (overall period)
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set type |
Intention-to-treat | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
An open-labeled, non-randomized, single arm trial with the treatment regimen consisted of paclitaxel 250 mg/m2 on day 1, ifosfamide 1200 mg/m2 on days 1-5, and cisplatin 20 mg/m2 on days 1-5, given intravenously every 21 days, totally for four cycles
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
TIP -Paclitaxel, Ifosfamid, Cisplatin
|
||
Reporting group description |
4 cycles of TIP regimen: Taxol 250 mg/ m2 iv on day 1 Ifosfamid 1,2 g/ m2/ day iv x 5 days Cisplatin 20 mg/ m2/ day iv x 5 days. One cycle of therapy consists of 21 days. | ||
Subject analysis set title |
Overall study (overall period)
|
||
Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
An open-labeled, non-randomized, single arm trial with the treatment regimen consisted of paclitaxel 250 mg/m2 on day 1, ifosfamide 1200 mg/m2 on days 1-5, and cisplatin 20 mg/m2 on days 1-5, given intravenously every 21 days, totally for four cycles
|
||
|
||||||||||
End point title |
Complete Response Rate | |||||||||
End point description |
Complete response to chemotherapy alone is defined as disappearance of all clinical, radiographic, and biochemical evidence of disease for at least 4 weeks; this includes patients in
whom surgical resection of residuum yields necrotic debris, fibrosis, or mature teratoma but no evidence of viable malignant tumor.
Complete response to chemotherapy plus surgery is defined as complete excision of all masses, at least one of which contained viable tumor other than mature teratoma.
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
Complete Response Rate was calculated from the start of the treatment until progression or death.
|
|||||||||
|
||||||||||
| Notes [1] - A CR was achieved in four subjects, therefore, the study was terminated in the first stage. [2] - A CR was achieved in four subjects, therefore, the study was terminated in the first stage. |
||||||||||
Statistical analysis title |
descriptive statistics | |||||||||
Comparison groups |
TIP -Paclitaxel, Ifosfamid, Cisplatin v Overall study (overall period)
|
|||||||||
Number of subjects included in analysis |
40
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
other | |||||||||
P-value |
< 5 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
||||||||||
|
||||||||||
End point title |
Toxicity grade 3/4 | |||||||||
End point description |
Adverse events will be assessed before each cycle of chemotherapy according to the NCI Common Toxicity Criteria (CTC) version 4.1.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Adverse events will be assessed from the start of the first chemotherapy until 28 days of completion of last chemotherapy.
|
|||||||||
|
||||||||||
| Notes [3] - any grade 3/4 txity had 9 subjects, 47,4 % |
||||||||||
| No statistical analyses for this end point | ||||||||||
|
||||||||||
End point title |
Response rate | |||||||||
End point description |
Objective response rate is defined as sum of complete and partial responses.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
From the beginning of the treatment until progression or death or start of new anticancer treatment.
|
|||||||||
|
||||||||||
| Notes [4] - A favorable response rate (CR or PR with negative tumor markers) was observed in 15 subjects. |
||||||||||
| No statistical analyses for this end point | ||||||||||
|
|||||||||||||
End point title |
progression-free-survival | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From the beginning of the treatment until progression or death.
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Overall survival | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
OS was calculated from the date of starting the treatment with TIP to the date of death or last follow-up.
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Adverse events wee reccorded from start of study tretment until 28 days after last chemotherapy administration.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
all subjects
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Grade 3 and 4 non serious or any grade serious adverse events are reported. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
15 May 2019 |
Protocol ver.2.0 dated 15May2019. |
||
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. | |||
| None reported | |||
