Unique ID issued by UMIN | UMIN000009812 |
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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 |
Japan multicenter prospective study: FDG PET/CT in the assessment of advanced renal cell carcinoma treated with sorafenib
Japan multicenter prospective study: FDG PET/CT Assessment of advanced Kidney cancer study (J-PEAK )
Japan multicenter prospective study: FDG PET/CT in the assessment of advanced renal cell carcinoma treated with sorafenib
Japan multicenter prospective study: FDG PET/CT Assessment of advanced Kidney cancer study (J-PEAK )
Japan |
renal cell carcinoma
Urology |
Malignancy
NO
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.
Efficacy
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
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)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Device,equipment |
FDG PET/CT at 4 weeks after treatment start
20 | years-old | <= |
Not applicable |
Male and Female
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
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
50
1st name | |
Middle name | |
Last name | Noboru Nakaigawa |
Yokohama City University
Graduate School of Medicine
Department of Urology
3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, 236-0004 Japan
045-787-2679
nakaigan@med.yokohama-cu.ac.jp
1st name | |
Middle name | |
Last name | Noboru Nakaigawa |
Yokohama City University
Department of Urology
3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, 236-0004 Japan
045-787-2679
nakaigan@med.yokohama-cu.ac.jp
Japan PET/CT Assessment of advanced Kidney cancer study group(J-PEAK group )
Bayer Yakuhin, Ltd.
Profit organization
NO
2013 | Year | 01 | Month | 20 | Day |
Unpublished
Open public recruiting
2013 | Year | 01 | Month | 11 | Day |
2013 | Year | 01 | Month | 21 | Day |
2013 | Year | 01 | Month | 19 | Day |
2017 | Year | 04 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011500
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