UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010201 |
|---|---|
| Receipt number | R000011948 |
| Scientific Title | Multicenter study of cisplatin-based chemotherapy with short hydration for lung cancer patients |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2015/03/09 12:04:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multicenter study of cisplatin-based chemotherapy with short hydration for lung cancer patients
Acronym
Multicenter study of cisplatin-based chemotherapy with short hydration for lung cancer patients
Scientific Title
Multicenter study of cisplatin-based chemotherapy with short hydration for lung cancer patients
Scientific Title:Acronym
Multicenter study of cisplatin-based chemotherapy with short hydration for lung cancer patients
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of short hydration in cisplatin-based chemotherapy for lung cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Proportion of patients without grade 2 or worse elevation of creatinine after cisplatin-based chemotherapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
hydration(intravenous, oral), antiemetics
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. Histologically or cytologically diagnosed lung cancer
2. Cisplatin (60mg/m2 or over)-based chemotherapy
3. Without treatment history of cisplatin
4. 20-74 year old
5. ECOG Performance Status 0 - 1
6. Appropriate organ function
7. Normal kidney function
(1) Cr value under normal limit
(2) Creatinine clearance over 60ml/min
Key exclusion criteria
1. Comorbidity (congestive heart failure, angina, myocardial infarction)
2. Pleural effusion, pericardial effusion, ascites, brain metastases, bone metastases which needs intervention
3. Active infection
4. Steroid treatment
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaoru Kubota |
Organization
Nippon Medical School Hospital
Division name
Medical Oncology Division
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidehito Horinouchi |
Organization
National Cancer Center Hospital
Division name
Thoracic oncology
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
日本医科大学附属病院、国立がん研究センター中央病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | 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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 09 | Day |
Last modified on
| 2015 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011948
