The assessment of the response to everolimus of renal cell carcinoma by FDG PET/CT and its impact on prognosis

Not Applicable

Recruiting

• Conditions: advanced renal cell carcinoma (RCC)

• Registration Number: JPRN-UMIN000011570
• Lead Sponsor: Yokohama City University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-25
• Study Completion: 2018-05-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Patients who meet any of the following are excluded from the study. (1)Concurrent antitumor treatment other than everolimus is given. (2)Prior treatment with more or 2 tyrosine kinase inhibitors (3)Prior treatment of treatment with mTOR inhibitors (temsirolimus or everolimus) (4)Prior treatment with chemotherapy with antitumor drug, regardless of cytokine therapy (5)Poorly-controlled diabetes mellitus (fasting blood glucose more than 150 g/dL) (6)Pregnant and/or nursing woman, possibility of pregnancy (7)History of organ transplantation (including bone marrow transplantation) (8)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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship between maximum standardized uptake value (SUVmax) at four weeks after everolimus treatment onset and Progression-free survival. SUVmax: the highest SUV in all RCC lesions in the individual patient

Secondary Outcome Measures

Name	Time	Method
A.Relationship between radiological parameters (1)-(3) and clinical outcome as below is exploratory evaluated. 1.Progression-free survival 2.Overall survival Relationship between laboratory data and prognosis Safety (adverse events) and QoL Radiological parameters (1)FDG-PET/CT observation at baseline, SUVmax,(Sigma)TLG, and SUL, and tumor size TLG: Total Lesion Glycilysis(g)=SUVmean(g/ml) x Volume(ml) SUL (SUV corrected by lean body mass ) (2)FDG-PET/CT observation at 4W after treatment start, especially change in SUVmax, (Sigma)TLG, SUL, and tumor size. (3)Presence/absence of new lesion B. the association of prognosis and laboratory data C. change of QOL by everolimus treatment