Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma (CROSS-J-RCC)
The clinical benefits of sunitinib and sorafenib have been demonstrated in patients with cytokine-refractory metastatic renal cell carcinoma. Sunitinib has also been shown to improve progression free survival and overall survival in a comparative study with interferon-alpha. When sunitinib is used as first-line molecular-targeted therapy, switching to sorafenib is one of the treatment options after disease progression. Reversely, when sorafenib is used as first-line molecular-targeted therapy, sunitinib is used as second-line therapy. The goal of cancer treatment is cure, and if cure is not possible, it is to prolong survival. In this study, sunitinib or sorafenib will be administered as first-line molecular-targeted therapy and treatment switched to the other test drug, sorafenib or sunitinib, when disease progression is detected to assess which treatment sequence produces longer progression free survival and offers a better safety profile (causing fewer adverse events). The purpose of this trial is to compare progression free survival of first line sunitinib versus sorafenib, and that of two treatment sequences, i.e. sunitinib followed by sorafenib versus sorafenib followed by sunitinib.
Metastatic Renal Cell Carcinoma
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma|
- Progression free survival in first-line treatment [ Time Frame: Time of progression in first line treatment ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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
|Yamagata University Faculty of Medicine|
|Yamagata, Japan, 990-9585|
|Principal Investigator:||Yoshihiko Tomita, MD||Yamagata University Faculty of Medicine|