Sunitinib given at 50 mg/day on schedule 4/2 (4 weeks on treatment, 2 weeks off) is the standard care for first-line treatment of metastatic renal cell carcinoma, but the schedule was reported with a high rate of dose reduction and dose discontinuation because of the safety profile. So investigators conducte this randomized, multi-center phase II study to determine whether a sunitinib regimen of 50 mg/day 2-weeks on/1-week off could provide the same efficacy in terms of progression-free survival, objective response, and overall survival, while reducing drug-related toxicity.
Sunitinib given at 50 mg/day on schedule 4/2 (4 weeks on treatment, 2 weeks off) is the standard care for first-line treatment of metastatic renal cell carcinoma, but the schedule was reported with a high rate of dose reduction and dose discontinuation because of the safety profile. Sunitinib 50mg/day on schedule 2/1 (2 weeks on treatment, 1 weeks off) was reported to be associated with significantly decrease toxicities in patients who initially experienced grade 3 or greater toxicity on the schedule 4/2 and could extend treatment duration considerably. Through this research, we would like to explore whether the schedule 2/1 of sunitinib 50 mg/day as first line therapy could provide the same efficacy as standard schedule 4/2 in terms of progression-free survival, objective response, and overall survival, while reducing drug-related toxicity in metastatic renal cell carcinoma patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
altenative schedules of sunitinib as first line therapy in metastatic renal cell carcinoma patients.
Chinese acadamy of medical science cancer institute & hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGPeking University First Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen university cancer center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGCancer Hospital, Fudan University
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGTianjin medical university cancer institute & hospital
Tianjin, Tianjin Municipality, China
NOT_YET_RECRUITINGprogress-free survival (PFS)
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 March 2017 cut off date
Time frame: 2 years
The percentage of patients who can get complete response, partial response.
Time frame: 2 years
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