UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019393
Receipt number R000021979
Scientific Title Consideration the changes of renal function for renal cell carcinoma patients, administered the molecular target drugs: axitinib, sunitinib and sorafenib
Date of disclosure of the study information 2015/10/19
Last modified on 2015/10/19 08:19:49

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Basic information

Public title

Consideration the changes of renal function for renal cell carcinoma patients, administered the molecular target drugs: axitinib, sunitinib and sorafenib

Acronym

Consideration the changes of renal function for renal cell carcinoma patients, administered the molecular target drugs

Scientific Title

Consideration the changes of renal function for renal cell carcinoma patients, administered the molecular target drugs: axitinib, sunitinib and sorafenib

Scientific Title:Acronym

Consideration the changes of renal function for renal cell carcinoma patients, administered the molecular target drugs

Region

Japan


Condition

Condition

Renal cell carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We consider the changes of renal function by administering the molecular target drugs: axitinib, sunitinib or sorafenib, for which the dose is determined for each

Basic objectives2

Others

Basic objectives -Others

We consider a therapeutic effect by administering the molecular target drugs: axitinib, sunitinib or sorafenib, for which the dose is determined for each. Therapeutic effect for target lesions is measured by using CT.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

For renal cell carcinoma patients, we evaluate the blood exam containing a renal function 1,2,4 and 12 weeks later from administration of the molecular target drugs whose daily doses are determined by eGFR (axitinib 10mg, sorafenib 800mg, sunitinib 50mg on over 45), (axitinib 6mg, sorafenib 800mg, sunitinib 37.5mg on low by 45).

Key secondary outcomes

We consider a therapeutic effect by administering the molecular target drug that is axitinib, sunitinib or sorafenib. Therapeutic effect for target lesions is examined using CT. The time for measuring is before and 4, 12weeks later from administration. For the case with preoperative setting, PET is performed before and after administration.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Pseudo-randomization


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A daily dose of the molecular target drug, axitinib is determined by eGFR (10mg on over 45, 6mg on low by 45). We evaluate the blood exam containing a renal function 1,2,4 and 12 weeks later from administration of the molecular target drug. And, we evaluate the lesion by CT before and 4, 12 weeks later from administration of the molecular target drug.

Interventions/Control_2

A daily dose of the molecular target drug, sunitinib is determined by eGFR (50mg on over 45, 37.5mg on low by 45). And, we evaluate the lesion by CT before and 4, 12 weeks later from administration of the molecular target drug.

Interventions/Control_3

A daily dose of the molecular target drug, sorafenib is determined as 800mg. And, we evaluate the lesion by CT before and 4, 12 weeks later from administration of the molecular target drug.

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

Renal cell carcinoma with target lesion

Key exclusion criteria

Renal cell carcinoma without target lesion

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hironori Betsunoh

Organization

Dokkyo Medical University

Division name

Urology

Zip code


Address

880Kitakobayashi Mibu, Shimotsuga Tochigi 321-0293 JAPAN

TEL

0282872162

Email

hirobets@dokkyomed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hironori Betsunoh

Organization

Dokkyo Medical University

Division name

Urology

Zip code


Address

880Kitakobayashi Mibu, Shimotsuga Tochigi 321-0293 JAPAN

TEL

0282872162

Homepage URL


Email

hirobets@dokkyomed.ac.jp


Sponsor or person

Institute

Dokkyo Medical University, Department of Urology

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


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

獨協医科大学


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 19 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

Enrolling by invitation

Date of protocol fixation

2015 Year 07 Month 14 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 19 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

2015 Year 10 Month 19 Day

Last modified on

2015 Year 10 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021979


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name