UMIN-CTR Clinical Trial

Public title

Prognostic evaluation with focus on renal function of molecular target drugs for Unresectable or Metastatic Renal Cell Carcinoma patients with Renal Dysfunction

Acronym

Prognostic evaluation with focus on renal function of molecular target drugs for Unresectable or Metastatic Renal Cell Carcinoma patients with Renal Dysfunction

Scientific Title

Prognostic evaluation with focus on renal function of molecular target drugs for Unresectable or Metastatic Renal Cell Carcinoma patients with Renal Dysfunction

Scientific Title:Acronym

Prognostic evaluation with focus on renal function of molecular target drugs for Unresectable or Metastatic Renal Cell Carcinoma patients with Renal Dysfunction

Region

Japan

Condition

Renal cell carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of sorafenib in patients with Renal cell carcinoma with impaired renal function

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

eGFR(every 4 weeks)

Key secondary outcomes

overall Survival
Progression Free Survival(PFS)
Response Rate(CR+PR)
Safety
To confirm the molecular target drug usage before and after

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administration of sorafenib

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Histologically proven Renal cell carcinoma
(2)Over 20yrs
(3)PS:0-1(ECOG grade)
(4)eGFR<90ml/min(including dialysis patients)
(5)Surgically unresectable
(6)Life Expectancy must be >=6 months
(7)Adequate hematologic, hepatic and respiratory function
(8)Interval of at least 2 weeks between prior treatment and start of present study
(9)Written informed consent

Key exclusion criteria

(1)Presence or past history of interstitial pneumonia or pulmonary fibrosis or possible
(2)Active infections(excluding viral hepatitis)
(3)Severe cardiac disorder, renal disorder, liver disorder, ulcer with bleeding, intestinal tract paralysis, uncontrollable diabetes mellitus
(4)Presence of pleural effusion or ascites requiring drainage
(5)Presence of metastasis in central nerve system
(6)Active double cancer except carcinoma in situ or intramucosal cancer(synchronous double or asynchronous double cancer with disease free duration to be within 3 years)
(7)Pregnant females or nursing mothers who can not stop lactation.Patients or partners, who do not attempt to doing contraception during the study period.
(8)Severe mental disorder
(9)Severe drug hypersensitivity
(10)As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the trial.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Toshiro Suzuki

Organization

Shinshu University school of medicine

Division name

Department of Urology

Zip code

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

+81263372661

Email

yokoso1046@shinshu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Toshiro Suzuki

Organization

Shinshu University school of medicine

Division name

Department of Urology

Zip code

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

+81263372661

Homepage URL

Email

yokoso1046@shinshu-u.ac.jp

Institute

Shinshu University school of medicine

Institute

Department

Personal name

Organization

Shinshu University school of medicine

Organization

Division

Category of Funding Organization

Other

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

Date of disclosure of the study information

2016

Year

04

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

Terminated

Date of protocol fixation

2015

Year

09

Month

01

Day

Date of IRB

Anticipated trial start date

2015

Year

09

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

04

Month

19

Day

Last modified on

2017

Year

10

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025336