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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004988
Receipt No. R000005928
Scientific Title Pharmacokinetic analysis of carboplatin in cancer patients with severe renal insufficiency.
Date of disclosure of the study information 2011/02/01
Last modified on 2014/01/31

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Basic information
Public title Pharmacokinetic analysis of carboplatin in cancer patients with severe renal insufficiency.
Acronym Pharmacokinetic analysis of carboplatin in cancer patients with severe renal insufficiency.
Scientific Title Pharmacokinetic analysis of carboplatin in cancer patients with severe renal insufficiency.
Scientific Title:Acronym Pharmacokinetic analysis of carboplatin in cancer patients with severe renal insufficiency.
Region
Japan

Condition
Condition advanced cancer with severe renal insufficiency
Classification by specialty
Pneumology Nephrology Chest surgery
Obsterics and gynecology Oto-rhino-laryngology Orthopedics
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish the optimal dose of carboplatin in cancer patients with severe renal insufficiency.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Safty
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 1)The dose of carboplatin is determined using the Calvert formula
2)For patients who don't undergo hemodialysis, the accurate GFR is estimated on the basis of inulin clearance
3)Blood samples (10 to 11 points)are collected after the first administration of carboplatin to study of its pharmacokinetics
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically proven advanced cancer
2) Age>=20years
3) Planned to receive carboplatin chemotherapy which is monotherapy or is combined paclitaxel, docetaxel,gemcitabine,etoposide and irinotecan
4) Severe renal insufficiency: eGFR<30mL/min/1.73m2, including patients who undergo hemodialysis
5) No chemotherapy with any antineoplastic agents within the past 4 weeks
Patients who recieved cisplatin based chemotherapy within the past 12 weeks are ineligible
6) ECOG PS:0-2
7) It doesn't asked patients have mesurabel lesion or not
8 )Adequate organ function except renal function
white-cell count>= 3,000/uL
platelet count>= 100,000/uL
hemoglobin concentration >= 9.0g/uL
AST/ALT<= 3x institutional upper limit of normal
Total bilirubin<= 1.5 x institutional upper limit of normal
9)Written informed consent
10)Life expectancy more than 2 months
Key exclusion criteria 1)Accumulation of coelomic fluid (e.g.,pleural effusion,ascites fluid)requiring regular drainage and/or any other surgical intervention during the trial
2)Patients with clinically significant serious infectious disease at the time of screening
3)Patient is judged by investigator to be inappropriate for study participation for serious psychiatric condition
4)Patient is judged by investigator to be inappropriate for study participation for any reason
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Ando
Organization Nagoya university hospital
Division name Clinical oncology and chemotherapy
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya-shi Aichi-ken
TEL 052-744-1903
Email yando@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyo Oguri
Organization Nagoya university hospital
Division name Respiratory medicine
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya-shi Aichi-ken
TEL 052-744-2167
Homepage URL
Email tomonet3@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya university hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Nagoya university hospital, Department of Nephrology
Kumamoto university hospital, Department of
Pharmacy
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 名古屋大学医学部附属病院(愛知県)
Nagoya university hospital(Aichi)

Other administrative information
Date of disclosure of the study information
2011 Year 02 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 Open public recruiting
Date of protocol fixation
2011 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 04 Month 01 Day
Date analysis concluded
2013 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 31 Day
Last modified on
2014 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005928

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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