Renal cell carcinoma
Conditions
Interventions
targeting therapy (TKI or mTORi) for aboout 3 months, and then, undergo radical nephrectomy
Sponsors
Hirosaki University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males, 20 years or older, in patients with advanced renal cell carcinoma without prior targeting therapy. Clinically T3-4, or oligometastatic disease (not multiple, small, or resectable) who underwent tumor biopsy prier to targeting therapy Agree to use TKI or mTORi prior to radical nephrectomy.
Exclusion criteria
Exclusion criteria: Sarcomatous renal cell carcinoma, not indicated for tyrosine kinase inhibitors(TKI) or mammalian target of rapamycin inhibitors(mTORi), untreated brain metastasis, active gastrointestinal hemorrhage, poor general health (ECOG PS > 2), major concomitant disease, other medical condition likely to result in death within 6 months after the treatment initiation. Clinical evidence of any of unstable diseases including cardiovascular, infectious, immune, nervous system disease, and other active malignancies that influenced on therapy for renal cell carcinoma. History of drug, alcohol, or substance abuse. Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to targeting therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adiologic tumor response comparison among Response Evaluation Criteria in Solid Tumors (RECIST), Choi, and contrast medium enhancement reduction (CMER) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological downstaging, theatment related adverse events (AE), postoperative complications, Ki67/MIB1 status, and tumor necrosis, pathological and molecular analysis to predict poor prognosis, progression free, cancer specific and overall survival | — |
Countries
Japan
Contacts
Public ContactShingo Hatakeyama
Hirosaki University Hospital Urology
Outcome results
None listed