UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009812
Receipt number R000011500
Scientific Title Japan multicenter prospective study: FDG PET/CT in the assessment of advanced renal cell carcinoma treated with sorafenib
Date of disclosure of the study information 2013/01/20
Last modified on 2017/04/29 15:07:19

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Basic information

Public title

Japan multicenter prospective study: FDG PET/CT in the assessment of advanced renal cell carcinoma treated with sorafenib

Acronym

Japan multicenter prospective study: FDG PET/CT Assessment of advanced Kidney cancer study (J-PEAK )

Scientific Title

Japan multicenter prospective study: FDG PET/CT in the assessment of advanced renal cell carcinoma treated with sorafenib

Scientific Title:Acronym

Japan multicenter prospective study: FDG PET/CT Assessment of advanced Kidney cancer study (J-PEAK )

Region

Japan


Condition

Condition

renal cell carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to investigate the relationship of the clinical outcome of patients with advanced renal cell carcinoma treated with sorafenib and radiological parameters obtained with FDG-PET/CT including maximum standardized uptake value (SUVmax) at baseline and change of SUVmax at four weeks after treatment onset. This study is multicenter-study using PET/CT systems which quality is ensured by previous phantom study.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relationship between radiological parameters (1)-(5) and Progression-free survival is exploratory evaluated.
radiological parameters
(1)FDG-PET/CT observation, especially SUVmax at baseline
(2)Second FDG-PET/CT observation, especially change in SUVmax at 4W after treatment start.
(3)Tumor size
(4)Presence/absence of new lesion
(5)Yokohama Response Criteria,especially the statistic difference between Intermediate responder and poor responder

Yokohama Response Criteria is defined as below: (Ueno D et al. BMC Cancer 2012)
Good responder:
SUVmax decreases more or 20%, and total of tumor size shows shrinkage or no change at 4W
Intermediate responder:
SUVmax decreases less than 20%, and total of tumor size shows shrinkage or no change at 4W
Poor responder:
Any SUVmax, and the total of tumor size or number increase at 4W

Key secondary outcomes

Relationship between radiological parameters (1)-(5) and clinical outcome as below is evaluated.
1.Overall survival
2.Response rate
3.Disease control rate

Radiological parameters
(1)FDG-PET/CT observation, especially SUVmax, TLG, and SUL at baseline
TLG: Total Lesion Glycilysis
SUL: SUV corrected by lean body mass
(2)Second FDG-PET/CT observation, especially change in SUVmax, TLG, and SUL at 4W after treatment start.
(3)Tumor size
(4)Presence/absence of new lesion
(5)Yokohama Response Criteria

Safety (adverse events)


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

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

FDG PET/CT at 4 weeks after treatment start

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

Patients who meet all of the following are eligible.
(1)Over or 20 years old
(2)Histologically confirmed advanced/recurrent RCC
(3)No prior treatment with molecular targeted agents (tyrosine kinase inhibitors, mTOR inhibitors) or only prior treatment with cytokine therapies
(4)Treatment with sorafenib is scheduled and the dose of sorafenib at start is more or 400mg/day.
(5)More than one target lesion defined by RECIST (v1.1)
(6)Major organ function conserved
(7)Life expectancy of more or 12 weeks
(8)With written informed consent

Key exclusion criteria

Patients who meet any of the following are excluded from the study.
(1)Concurrent antitumor treatment other than sorafenib is given.
(2)Prior treatment except cytokine therapies
(3)Poorly-controlled diabetes mellitus (fasting blood glucose is more than 150 g/dL)
(4)Pregnant and/or nursing woman, possibility of pregnancy
(5)History of organ transplantation (including bone marrow transplantation)
(6)History of malignancy except:
(i)Curatively treated intraepithelial cervical cancer, basal cell carcinoma, superficial bladder cancer (Ta, Tis and T1).
(ii)Patients who had been disease free more for than 3 years after curative therapy

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noboru Nakaigawa

Organization

Yokohama City University
Graduate School of Medicine

Division name

Department of Urology

Zip code


Address

3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, 236-0004 Japan

TEL

045-787-2679

Email

nakaigan@med.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noboru Nakaigawa

Organization

Yokohama City University

Division name

Department of Urology

Zip code


Address

3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, 236-0004 Japan

TEL

045-787-2679

Homepage URL


Email

nakaigan@med.yokohama-cu.ac.jp


Sponsor or person

Institute

Japan PET/CT Assessment of advanced Kidney cancer study group(J-PEAK group )

Institute

Department

Personal name



Funding Source

Organization

Bayer Yakuhin, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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



Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 20 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

2013 Year 01 Month 11 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 21 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 01 Month 19 Day

Last modified on

2017 Year 04 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011500


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name