ARCC (Hudes) temsirolimus alone, 2007 trial summary    PDF trial summary

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

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NCT00065468    N Engl J Med 2007;356:2271-81  



Studied treatment 25 mg of intravenoustemsirolimus weekly
Control treatment 3 million U of interferon alfa (with an increase to 18 millionU) subcutaneously three times weekly

3 arms: Temsirolimus alone, Temsirolimus plus interferon and interferon alone



Patients patients with previously untreated, poor-prognosis metastatic renal-cell carcinoma
Group sizes209 / 207
treatment line line 1



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



EndpointX1N1X0N0TE95% CI OS - 209 - 207 0,73[0,58; 0,92] PFS - 209 - 207 no data0,22,01,0

Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, Staroslawska E, Sosman J, McDermott D, Bodrogi I, Kovacevic Z, Lesovoy V, Schmidt-Wolf IG, Barbarash O, Gokmen E, O'Toole T, Lustgarten S, Moore L, Motzer RJ Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007;356:2271-81     [PMID: 17538086]   link to pdf   add to Mendeley  

ClinicalTrial.gov record NCT00065468



Registering number NCT00065468 (see trial on clinicaltrials.gov)
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