UMIN-CTR Clinical Trial

Public title

Japan multicenter prospective study: FDG-PET/CT as imaging biomarker to evaluate the response of Axitinib for Sunitinib failed metastatic renal cell carcinoma patients.

Acronym

FDG-PET/CT as imaging biomarker to evaluate the response of Axitinib for Sunitinib failed mRCC patients.

Scientific Title

Japan multicenter prospective study: FDG-PET/CT as imaging biomarker to evaluate the response of Axitinib for Sunitinib failed metastatic renal cell carcinoma patients.

Scientific Title:Acronym

FDG-PET/CT as imaging biomarker to evaluate the response of Axitinib for Sunitinib failed mRCC patients.

Region

Japan

Condition

renal cell carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

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 axitinib after sunitinib treatment and radiological parameters obtained with FDG-PET/CT including maximum standardized uptake value (max SUVmax) before and four weeks after axitnib 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

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Relationship between radiological parameters (1)-(5) and progression-free survival and overall survival is exploratory evaluated.
(1) First FDG-PET/CT observation before axitinib onset, especially max SUVmax*.
(2) Second FDG-PET/CT observation at 4W after axitinib treatment start, especially max SUVmax
(3) Change ratio in max SUVmax.
=max SUVmax at 4W after axitinib treatment start / max SUVmax before axitinib treatment start
(4) Tumor size
(5) Presence/absence of new lesion
*max SUVmax: the highest SUV in the individual patient

Key secondary outcomes

Relationship between radiological parameters (1)-(6) and clinical outcome as below is exploratory evaluated.
1. Overall survival
2. Response rate
3. Disease control rate

Radiological parameters
(1) SUVmean
(2) Sigma TLG
(3) SUL (SUV corrected by lean body mass )
(4) Tumor size
(5) The location of tumor (organ where tumor locates)
(6) SUV max** of each tumor
**SUVmax: the highest SUV in the individual RCC tumor

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

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Design of this study is prospective, multi-centered, single arm, interventional phase II study. Only the patients who are planned to receive axitinib treatment after sunitinib treatment are enrolled in this study, and the treatment with axitinib is performed within the label of the drug as daily medical practice. Therefore the study is non-interventional in terms of treatment with axitinib. However, because the second FDG-PET/CT for evaluation of treatment efficacy is beyond the daily medical practice, this study is interventional.

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

Patients who meet all of the following are eligible.
(1) Over 20 years old
(2) Histologically confirmed advanced/recurrent RCC
(3) Received the treatment by sunitinib
(4) More than one target lesion defined by RECIST (v1.1)
(5) Major organ function conserved
(6) Life expectancy of  12 weeks
(7) With written informed consent

Key exclusion criteria

Patients who meet any of the following are excluded from the study.
(1) Poorly-controlled diabetes mellitus (fasting blood glucose  150 g/dL)
(2) History of organ transplantation (including bone marrow transplantation)
(3) 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
(4) Central nervous system metastases. However, patients who remain asymptomatic, have no new or enlarging lesion in the CNS within 6 months of enrollment in this study
(5) History of cardiac infarction, unstable angina, congestive heart failure, or symptomatic peripheral vascular disease within 12 months of enrollment
(6) History of cerebrovascular disorder including transient ischemic attack (TIA)
(7) Pregnant and/or nursing woman, possibility of pregnancy

Target sample size

50

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

TEL

045-787-2679

Email

nakaigan@med.yokohama-cu.ac.jp

Name of contact person

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

TEL

045-787-2679

Homepage URL

Email

nakaigan@med.yokohama-cu.ac.jp

Institute

Yokohama City University

Institute

Department

Personal name

Organization

Pfizer Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

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

横浜市立大学附属病院

Date of disclosure of the study information

2013

Year

12

Month

11

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

Open public recruiting

Date of protocol fixation

2013

Year

10

Month

18

Day

Date of IRB

Anticipated trial start date

2013

Year

12

Month

11

Day

Last follow-up date

2016

Year

11

Month

30

Day

Date of closure to data entry

2017

Year

11

Month

30

Day

Date trial data considered complete

2017

Year

11

Month

30

Day

Date analysis concluded

2018

Year

11

Month

30

Day

Other related information

Registered date

2013

Year

12

Month

10

Day

Last modified on

2014

Year

01

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014206