UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053657 |
|---|---|
| Receipt number | R000061229 |
| Scientific Title | A phase II study of cisplatin short hydration without diuretics. |
| Date of disclosure of the study information | 2024/02/26 |
| Last modified on | 2024/02/20 11:07:54 |
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Basic information
Public title
A phase II study of cisplatin short hydration without diuretics.
Acronym
A phase II study of cisplatin short hydration without diuretics.
Scientific Title
A phase II study of cisplatin short hydration without diuretics.
Scientific Title:Acronym
A phase II study of cisplatin short hydration without diuretics.
Region
| Japan |
Condition
Condition
Chemotherapy naive thoracic malignancy
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of cisplatin short hydration without diuretics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The proportion of patients who did not observe a Grade 2 or higher creatinine increase after the first cycle(defined as elevation in creatinine, CTCAE Ver. 5.0, based on the upper limit of the normal range (ULN) for serum creatinine at each institute)
Key secondary outcomes
1)The proportion of patients without grade 2 or higher creatinine increase at end of cycle
2)The number of chemotherapy cycles
3)Response rate
4)The proportion of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Without diuretics administration
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
| 20 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Thoracic malignancy
2)Patients who are eligible for combination chemotherapy with cisplatin (60 mg/m2 or more) (including combination therapy with immune checkpoint inhibitors and molecular target therapy drugs, and chemoradiotherapy)
3)Previously untreated with cisplatin-based chemotherapy
4)Patients aged 20 to 74 years
5)ECOG PS 0-1
6)WBC > 3000, Neu > 1500, Hb > 9g/dL, PLT > 100000, AST < 100IU/L, ALT < 100IU/L, T-Bil < 1.5mg/dL, SpO2 > 95% (room air)
7)Creatinine is below the upper limit normal range and creatinine clearance is 60mL/min or more
8)Patients with sufficient oral intake
9)Patients who have given written informed consent
Key exclusion criteria
1)Severe recurrent laryngeal nerve palsy or mediastinal mass
2)Pericardial effusion, pleural effusion, or ascites, with accumulation of fluid to a degree that requires drainage
3)Symptomatic brain metastases
4)Spinal metastases requiring urgent radiation or surgical treatment
5)Heart failure, unstable angina, myocardial infarction, acute kidney disease(within the past 6 months)
6)Complicated by poorly controlled diabetes even with continuous insulin use
7)Active infection(excluding viral hepatitis)
8)Receiving continuous systemic steroid therapy
9)Psychosis or comorbid psychiatric symptoms
10)Deemed inappropriate by attending physician
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Kubota |
Organization
Nippon Medical School Hospital
Division name
Department of Pulmonary Medicine and Oncology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
0338222131
kkubota@nms.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Wako |
Organization
Nippon Medical School Hospital
Division name
Department of Pharmacy Services
Zip code
1138603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
0338222131
Homepage URL
t-wako@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Nippon Medical School Hospital Drug Institutional Review Board
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
0338222131
inq-ccr@nms.ac.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
日本医科大学付属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 26 | 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
46
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
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 20 | Day |
Last modified on
| 2024 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061229
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| Registered date | File name |
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