renal cell carcinoma
Conditions
Interventions
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
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) 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNoboru Nakaigawa
Yokohama City University Graduate School of Medicine Department of Urology
Outcome results
None listed