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 nivolumab treatment are enrolled in this study, and the tre
Sponsors
Yokohama City University Graduate School of Medicine
Kanagawa Cancer Center Yokosuka Kyosai Hospital
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 renal cell carcinoma (3) Received the treatment by nivolumab (4) More than one target lesion defined by RECIST (v1.1) (5) 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 >150mg/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) Pregnant and/or nursing woman, possibility of pregnancy (5) Patient treated simultaneously by other antineoplastic therapeutic or therapy purposing antitumor effect except for nivolumab examples: chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy, hyperthermia, surgery (6) any other cases who are regarded as inadequate for study enrollment by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test the correlation between judging by FDG PET/CT at 4 weeks after treatment start and the evaluation of therapeutic effect based on RECIST using CT scan at 16 weeks. The criteria of judging by FDG PET/CT at 4 weeks Responder: the case who satisfies the following conditions 1) max SUVmax increases more or 20% 2)without new lesions Non-responder: the case who does not meet "responder" max SUVmax: the highest SUV in the individual patient | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the relation between the assessment by FDG PET/CT at 4 weeks and clinical outcome as below. 1. Progression-free survival 2. Overall survival 3. Response rate To search radiological parameter which predicts clinical outcome as below 1. Progression-free survival 2. Overall survival 3. Response rate To search clinical parameter which predicts clinical outcome as below 1. Progression-free survival 2. Overall survival 3. Response rate | — |
Countries
Japan
Contacts
Public ContactNoboru Nakaigawa
Yokohama City University Graduate School of medicine Department of Urology
Outcome results
None listed