Sutent Rechallenge In mRCC Patients (RESUME)
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About
Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.
Full description
A sample size of n = 40 patients will allow to estimate of the median PFS with a precision around 1.8 months (based on data from Rini et al.) This retrospective and prospective study is designed to estimate the effect of Sutent rechallenge.
The PFS (estimated from Kaplan-Meier estimate) will be the primary endpoints. In addition, the effects of sunitinib at the 2 periods of treatment (i.e. first line sunitinib vs. rechallenge) will be compared by Wilcoxon signed-rank test for PFS values and by McNemar test for overall response rate (ORR).
Enrollment
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Inclusion criteria
- Histologically documented metastatic RCC containing predominantly clear cell component.
- Previously received sunitinib in first line, 2 or more antitumor therapies subsequently and then received sunitinib for a second time.
- At least 1 cycle of sunitinib rechallenge (1 cycle= 4 weeks on/2 weeks off).
- At least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter (LD) ³ 10 mm when measured by spiral computerized tomography (CT) (5-mm slice thickness contiguous) or ³ 20 mm when measured by conventional CT (10-mm slice thickness contiguous). The lesion must be ³ 2 times the size of the slice thickness per RECIST criteria.
- Life expectancy of at least 3 months.
Exclusion criteria
- Patient who didn't receive Sunitinib in first line.
- Patient who received less than one line of treatment .
Trial design
61 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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