Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma (CROSS-J-RCC)
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|ClinicalTrials.gov Identifier: NCT01481870|
Recruitment Status : Unknown
Verified February 2013 by Yoshihiko TOMITA, Yamagata University.
Recruitment status was: Active, not recruiting
First Posted : November 30, 2011
Last Update Posted : February 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Renal Cell Carcinoma||Drug: Sorafenib-sunitinib Drug: Sunitinib-sorafenib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||December 2015|
Active Comparator: Sorafenib-sunitinib
Sorafenib is first line treatment followed by sunitinib.
sorafenib 400mg b.i.d. followed by sunitinib treatment when progression is observed
Active Comparator: Sunitinib-sorafenib
Sunitinib is first line treatment followed by sorafenib.
sunitinib 50mg q.d. 4 weeks on two weeks off followed by sorafenib treatment when progression is observed
- Progression free survival in first-line treatment [ Time Frame: Time of progression in first line treatment ]From date of randomization until the date of first documented progression of the first line treatment or date of death from any cause, whichever came first, assessed up to 36 months.
- Total progression free survival (PFS) in first-line and second-line treatments [ Time Frame: Time of progression in second line treatment ]From date of randomization until the date of first documented progression of the second line treatment or date of death from any cause, whichever came first, assessed up to 36 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481870
|Yamagata University Faculty of Medicine|
|Yamagata, Japan, 990-9585|
|Principal Investigator:||Yoshihiko Tomita, MD||Yamagata University Faculty of Medicine|