Clinical Trial: Sorafenib Combined With Chemotherapy for Renal Collecting Duct Carcinoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Sorafenib Combined With Cisplatin and Gemcitabine for the Treatment of Patients With Advanced Renal Collecting Duct Carcinoma:A Pilot, Open Study

Brief Summary: The goal of this clinical research study is to learn the effectiveness of sorafenib combined with gemcitabine plus cisplatin in the treatment of patients with locally advanced or metastatic collecting duct carcinoma(CDC) of the kidney. The safety of each treatment will also be studied.

Detailed Summary: Collecting duct carcinoma(CDC) of the kidney is a rare and aggressive neoplasm of the distal collecting tubules for which there is no established treatment. Since the histology of collecting duct carcinoma is similar to that of urothelial carcinoma, a prospective phase II trial in France(2007) studied gemcitabine plus cisplatin as the first-line treatment of advanced CDC, resulting an effective rate of 26%. The targeted drugs can produce definite efficacy on renal clear cell carcinoma, but the data on targeted drugs for the treatment of renal advanced collecting duct carcinoma is limited. We sponsored this study based on the assumption that targeted drugs combined with chemotherapy can produce additive, positive effects in CDC.
Sponsor: Beijing Cancer Hospital

Current Primary Outcome: progress-free survival,PFS [ Time Frame: Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment until 30 June 2015 cut of date ]

Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause.


Original Primary Outcome: progress-free survival,PFS [ Time Frame: from Jun.1st, 2012 to Jun.1st, 2015 ]

the time span from enrolled to progress or death


Current Secondary Outcome: adverse event, AE [ Time Frame: Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment until 30 June 2015 cut of date ]

Any events,no matter related to interventions,occur during the period from the enrollment to death or 30 days after withdrawal from the trial


Original Secondary Outcome: adverse event, AE [ Time Frame: from Jun 1st,2012 to Jun 1st,2015 ]

Any events,no matter related to interventions,occur during the period from the enrollment to death or 30 days after withdrawal from the trial


Information By: Beijing Cancer Hospital

Dates:
Date Received: December 22, 2012
Date Started: June 2011
Date Completion: June 2017
Last Updated: May 7, 2017
Last Verified: May 2017