UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058123 |
|---|---|
| Receipt number | R000066435 |
| Scientific Title | Multicenter Analysis of Adverse Events Associated with Induction Chemotherapy in Metastatic Testicular Tumors: Age-Based Comparison of Patients Aged 50 Years and Older Versus Younger Than 50 Years |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/06/09 12:35:11 |
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Basic information
Public title
Multicenter Analysis of Adverse Events Associated with Induction Chemotherapy in Metastatic Testicular Tumors: Age-Based Comparison of Patients Aged 50 Years and Older Versus Younger Than 50 Years
Acronym
MATCH-50 (Metastatic testicular tumor Adverse event study by CHemotherapy in patients under/over 50)
Scientific Title
Multicenter Analysis of Adverse Events Associated with Induction Chemotherapy in Metastatic Testicular Tumors: Age-Based Comparison of Patients Aged 50 Years and Older Versus Younger Than 50 Years
Scientific Title:Acronym
MATCH-50 (Metastatic testicular tumor Adverse event study by CHemotherapy in patients under/over 50)
Region
| Japan |
Condition
Condition
metastatic testicular tumors
Classification by specialty
| Urology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to retrospectively observe the adverse events of BEP, EP, and VIP therapy as induction chemotherapy for metastatic testicular tumors in elderly patients aged 50 years or older using a retrospective database from multiple institutions, and to clarify their characteristics and frequency in comparison with those aged less than 50 years.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Types and incidence of adverse events associated with BEP, EP, and VIP therapy
Key secondary outcomes
1)Incidence of regimen changes in BEP, EP, and VIP therapy (proportion of patients who experienced a reduction in anticancer drug dosage, proportion of patients who experienced a skip, and proportion of patients who experienced a skip)
2)Response rate (PR+CR) and CR response rate in BEP, EP, and VIP therapy
3)Overall survival rate (OS, 1-year survival rate, and 3-year survival rate)
4) Disease-specific survival rate (CSS, 1-year survival rate, and 3-year survival rate)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
1)Patients with histologically proven testicular tumors
2)Patients with unresectable tumors or metastases to other organs
3)Patients who have received BEP, EP, or VIP therapy
Key exclusion criteria
1) Patients with active cancer originating in other organs at the start of BEP, EP, or VIP therapy
2) Patients with incomplete data or who cannot be followed up
Target sample size
183
Research contact person
Name of lead principal investigator
| 1st name | MIYAZAKI |
| Middle name | |
| Last name | JUN |
Organization
International University of Health and Welfare Narita Hospital
Division name
Renal and Urological Surgery
Zip code
286-8520
Address
852 Hatakeda Narita, Chiba Prefecture
TEL
0476-35-5600
a-katami@ihwg.jp
Public contact
Name of contact person
| 1st name | KATAMI |
| Middle name | |
| Last name | AKINOBU |
Organization
International University of Health and Welfare Narita Hospital
Division name
Renal and Urological Surgery
Zip code
286-8520
Address
852 Hatakeda Narita, Chiba Prefecture
TEL
0476-35-5600
Homepage URL
a-katami@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare Narita Hospital
Institute
Department
Personal name
KATAMI AKINOBU
Funding Source
Organization
International University of Health and Welfare Narita Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Narita Hospital
Address
852 Hatakeda Narita, Chiba Prefecture
Tel
0476-35-5600
a-katami@ihwg.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国際医療福祉大学成田病院(千葉県)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Overview of Research Methods
This study will focus on patients with metastatic testicular tumors who have previously received BEP, EP, or VIP therapy at participating institutions.
(2) Research Design
Patients will be divided into two groups: those aged 50 years or older and those under 50 years of age.
Patients with histologically confirmed testicular tumors
Patients with unresectable tumors or tumors that have metastasized to other organs
Patients who have previously received BEP, EP, or VIP therapy
This is a retrospective study conducted jointly by the International University of Health and Welfare Narita Hospital and the University of Tsukuba Hospital.
(3) Medications, medical devices, treatment methods, observation methods, etc., used in this study
None in particular.
(4) Statistical analysis methods
1) Survey and observation period
The survey and observation period for each registered patient in this study is the entire period from the start of systemic chemotherapy to the most recent date for which follow-up is possible.
2) Survey items
The principal investigator at the research institution will conduct surveys on registered patients regarding the following items.
1 Demographic data
Survey items: Age (at the start of chemotherapy), gender
2 Physical measurements and condition (at the start of chemotherapy)
Survey items: Height, weight, Performance Status (PS)
3 Complications
Record those that may influence drug selection.
Survey items: Cardiac dysfunction, hepatic dysfunction, etc., to be described freely.
4 Tumor status
Describe the treatment history of the primary tumor and its status at the start of BEP, EP, or VIP therapy.
Survey items: Treatment history of the primary tumor
(5) Details of chemotherapy
Survey items: Regimen (drug name, dose, administration date), dose reduction, etc.
Due to character limitations, I cannot write any more.
Management information
Registered date
| 2025 | Year | 06 | Month | 09 | Day |
Last modified on
| 2025 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066435
