Motzer, 2007 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of sunitinib versus interferon alpha in patients with previously untreated, metastatic renal-cell carcinoma

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NCT00083889    J Clin Oncol 2009;27:3584-90.  



Studied treatment repeated 6-week cycles of sunitinib (at a dose of 50 mg given orally once daily for 4 weeks, followed by 2 weeks without treatment)
Control treatment interferon alfa (at a dose of 9 MU given subcutaneously three times weekly).



Patients patients with previously untreated, metastatic renal-cell carcinoma
Group sizes375 / 375
treatment line line 1
cross over



Blindness Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint PFS Design



EndpointX1N1X0N0TE95% CI OS - 375 - 375 0,82[0,67; 1,00] PFS - 375 - 375 0,42[0,32; 0,55]0,22,01,0

Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007;356:115-24     [PMID: 17215529]   link to pdf   add to Mendeley  

Cella D, Li JZ, Cappelleri JC, Bushmakin A, Charbonneau C, Kim ST, Chen I, Motzer RJ, Quality of life in patients with metastatic renal cell carcinoma treated with sunitinib or interferon alfa: results from a phase III randomized trial. J Clin Oncol 2008;26:3763-9.     [PMID: 18669464]   link to pdf   add to Mendeley  

Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Oudard S, Negrier S, Szczylik C, Pili R, Bjarnason GA, Garcia-del-Muro X, Sosman JA, Solska E, Wilding G, Thompson JA, Kim ST, Chen I, Huang X, Figlin RA, Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol 2009;27:3584-90.     [PMID: 19487381]   link to pdf   add to Mendeley  

ClinicalTrial.gov record NCT00083889



Registering number NCT00083889 (see trial on clinicaltrials.gov)
Code Name