Efficacy of presurgical targeting therapy on tumor shrinkage in patients with advanced renal cell carcinoma

Not Applicable

• Conditions: Renal cell carcinoma

• Registration Number: JPRN-UMIN000025209
• Lead Sponsor: Hirosaki University Graduate School of Medicine

Brief Summary

The median radiologic tumor response by RECIST, Choi, and CMER was -19%, -24%, and -49%, respectively. Among the radiologic tumor response tests, CMER showed a higher association with tumor necrosis in surgical specimens than others. Ki67/MIB1 status was significantly decreased in surgical specimens than in biopsy specimens. The magnitude of the slope of the regression line associated with the tumor necrosis percentage was greater in CMER than in Choi and RECIST.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-10
• Study Completion: 2022-12-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
adiologic tumor response comparison among Response Evaluation Criteria in Solid Tumors (RECIST), Choi, and contrast medium enhancement reduction (CMER)

Secondary Outcome Measures

Name	Time	Method
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