CABOSUN, 2017 trial summary

A randomised clinical trial investigating the effect of cabozantinib versus sunitinib in untreated clear cell mRCC and Eastern Cooperative Oncology Group performance status of 0 to 2 and were intermediate or poor risk per International Metastatic Renal Cell Carcinoma Database Consortium criteria

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NCT01835158    J Clin Oncol 2017;35:591-597  
1st line



Studied treatment cabozantinib (60 mg once per day)
Control treatment sunitinib (50 mg once per day; 4 weeks on, 2 weeks off).



Patients untreated clear cell mRCC and Eastern Cooperative Oncology Group performance status of 0 to 2 and were intermediate or poor risk per International Metastatic Renal Cell Carcinoma Database Consortium criteria
Group sizes79 / 78
treatment line
cross over



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

phase 2



EndpointX1N1X0N0TE95% CI OS - 79 - 78 no data PFS - 79 - 78 0,66[0,46; 0,95]0,22,01,0

Choueiri TK, Halabi S, Sanford BL, Hahn O, Michaelson MD, Walsh MK, Feldman DR, Olencki T, Picus J, Small EJ, Dakhil S, George DJ, Morris MJ Cabozantinib Versus Sunitinib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma of Poor or Intermediate Risk: The Alliance A031203 CABOSUN Trial. J Clin Oncol 2017;35:591-597     [PMID: 28199818]   link to pdf   add to Mendeley  

ClinicalTrial.gov record NCT01835158



Registering number NCT01835158 (see trial on clinicaltrials.gov)
Code Name Alliance A031203