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Sutent Rechallenge In mRCC Patients

2015-05-21 21:23:26 | BioPortfolio

Summary

Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.

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).

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Conditions

Metastatic Renal Cell Carcinoma

Intervention

sunitinib: observational study

Location

CHU de la Timone
Marseille
Cedex 5
France
13335

Status

Completed

Source

Pfizer

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-05-21T21:23:26-0400

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Medical and Biotech [MESH] Definitions

A heterogeneous group of sporadic or hereditary carcinoma derived from cells of the KIDNEYS. There are several subtypes including the clear cells, the papillary, the chromophobe, the collecting duct, the spindle cells (sarcomatoid), or mixed cell-type carcinoma.

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