advanced renal cell carcinoma (RCC)
Conditions
Interventions
Design of this study is prospective, multi-centered, single arm, interventional phase II study. Only the patients who are planned to receive everolimus treatment are enrolled in this study, and the t
Sponsors
Yokohama City University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following are eligible. (1)Over 20 years old (2)Histologically confirmed advanced/recurrent RCC (3)Under or after treatment with 1st tyrosine kinase inhibitor (sorafenib, sunitinib, axitinib, or pazopanib) (4)Treatment with everolimus is scheduled and the dose of everolimus at start is more or 5.0mg/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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNoboru Nakaigawa
Yokohama City University Department of Urology
Outcome results
None listed