UMIN-CTR Clinical Trial

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

Renal cell carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Dokkyo Medical University, Department of Urology

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

獨協医科大学

Date of disclosure of the study information

2015

Year

10

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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