Prospective multicenter trial on the identification of novel biomarkers for Sunitinib therapy in the treatment of Japanese patients with metastatic renal cell carcinoma

Not Applicable

• Conditions: renal cell carcinoma

• Registration Number: JPRN-UMIN000009622
• Lead Sponsor: Tokyo metropolitan Sutent study group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2011-12-01
• Study Start: 2012-12-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

1.brain metastasis 2.uncontrollable hypertention 3.Active or symptomatic angina pectoris or coronary artery disease (myocardial infarction within 12 months or symptomatic unstable angina), Symptomatic congestive heart failure, Long QTc 4.History of being allergic to Sunitinib 5.Pregnant or lactating woman, including the possibility of pregnant 6.Post organ transplantation, including hematopoietic stem cell transplantation 7.History of malignancy, excluding following cases Cervical cancer (carcinoma in situ), Basal cell carcinoma, Superficial bladder cancer(Ta, Tis and T1, which have been treated properly Malignancies treated radically more than 3 years before, without recurrence 8.History of VEGF/ VEGF-R targeted therapy 9.Systemic treatment with steroids 10.Interstitial pneumonia

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
inflammation markers IL-6, CRP, IL-8, hepcidin immunologic markers Th1/Th2 bias, TReg, MDSC angiogenesis markers VEGF-C, soluble VEGFR-2, soluble VEGFR-3, b-FGF

Secondary Outcome Measures

Name	Time	Method
response rate, progression free survival, overall survival, safety