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 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 )

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009812

Enrollment

Registered

2013-01-20

Start date

2013-01-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal cell carcinoma

Interventions

FDG PET/CT at 4 weeks after treatment start

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

Japan

Contacts

Public ContactNoboru Nakaigawa

Yokohama City University Department of Urology

nakaigan@med.yokohama-cu.ac.jp045-787-2679

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026