UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059474 |
|---|---|
| Receipt number | R000068025 |
| Scientific Title | Retrospective study of cisplatin plus etoposide therapy in patients with lung cancer undergoing hemodialysis: the largest single-regimen cohort |
| Date of disclosure of the study information | 2025/10/21 |
| Last modified on | 2025/10/20 17:59:23 |
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Basic information
Public title
Retrospective study of cisplatin plus etoposide therapy in patients with lung cancer undergoing hemodialysis: the largest single-regimen cohort
Acronym
Retrospective study of cisplatin plus etoposide therapy in patients with lung cancer undergoing hemodialysis: the largest single-regimen cohort
Scientific Title
Retrospective study of cisplatin plus etoposide therapy in patients with lung cancer undergoing hemodialysis: the largest single-regimen cohort
Scientific Title:Acronym
Retrospective study of cisplatin plus etoposide therapy in patients with lung cancer undergoing hemodialysis: the largest single-regimen cohort
Region
| Japan |
Condition
Condition
Patients with Lung Cancer and end-stage renal failure undergoing HD
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the safety and efficacy of cisplatin and etoposide therapy in patients with end-stage renal disease undergoing maintenance hemodialysis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of non-hematologic toxicities of grade 3 or higher and hematologic toxicities of grade 4 or higher
Key secondary outcomes
response rate, progression free survival, overall survival, frequency of patients discontinued or delayed due to adverse events.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The following cases meeting criteria 1) and 2) are eligible.
1) Cases treated with CDDP+ETP for advanced or recurrent lung cancer between January 2000 and December 2024. Cases previously treated with single-agent molecularly targeted therapy or single-agent immune checkpoint inhibitor therapy are eligible.
2) Cases undergoing maintenance hemodialysis prior to initiation of chemotherapy for end-stage renal failure.
* Both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) are included.
* Cases treated with chemoradiotherapy will be included for adverse event collection but excluded from overall survival data.
Key exclusion criteria
Exclude cases meeting any of the following criteria:
1) Cases with cancer of unknown primary origin or cases receiving chemotherapy for malignant tumors other than lung cancer
2) Cases receiving chemotherapy for cancers other than lung cancer within six months prior to initiation of CDDP+ETP therapy
3) Cases requiring dialysis after starting chemotherapy for lung cancer
4) Cases receiving combination therapy with molecularly targeted drugs or immune checkpoint inhibitors alongside CDDP+ETP
5) Individuals who expressed refusal to participate in this study through the information disclosure document.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takuzi |
| Middle name | |
| Last name | Suzuki |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba
TEL
043-222-7171
suzutaku@chiba-u.jp
Public contact
Name of contact person
| 1st name | Mikihito |
| Middle name | |
| Last name | Saito |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba
TEL
09072717711
Homepage URL
saitoumikihito@gmail.com
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University 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
Ethics Committee for Observational Studies of Chiba University Hospital
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba
Tel
043-222-7171
hsp-kansaturinri@chiba-u.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 21 | 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 | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068025
