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Kidney

A Randomized Phase III Trial Of Interferon Alfa-2B Or Interferon Alfa-2B Plus Bevacizumab In Patients With Advanced Renal Carcinoma

Unique Dataset IDKidney_Allianc_2003_219
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderThe Alliance for Clinical Trials in OncologyTotal Study Enrolled Patients732Comparator (Control) Arm Enrolled Patients0Experimental (Active) Arm Enrolled Patients732RandomizationYesClinicalTrial.gov IDNCT00072046ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/record/NCT00072046?term=CALGB+90206&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeBiologicsDataset TypeADS

Clinical Trial Title

A Randomized Phase III Trial Of Interferon Alfa-2B Or Interferon Alfa-2B Plus Bevacizumab In Patients With Advanced Renal Carcinoma

Trial Summary and Conditions

RATIONALE: Biological therapies, such as interferon alfa-2b, may interfere with the growth of tumor cells. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether interferon alfa-2b is more effective with or without bevacizumab in treating advanced renal cell carcinoma (kidney cancer). PURPOSE: This randomized phase III trial is studying interferon alfa-2b and bevacizumab to see how well they work compared to interferon alfa-2b alone in treating patients with advanced renal cell carcinoma.

Data Summary

Control and experimental arm data files include data on safety, efficacy, demographics, etc. See the data dictionary provided for more details.

Study Objectives

Primary: To compare the overall survival for advanced renal cell carcinoma (RCC) patients receiving initial systemic therapy with interferon alfa-2b plus bevacizumab or interferon alfa-2b alone. Secondary: To compare the time to disease progression and objective response rates for advanced RCC patients receiving initial systemic therapy interferon alfa-2b plus bevacizumab or interferon alfa-2b alone. To determine the toxicity of interferon alfa-2b plus bevacizumab.

Outcome Measures

Primary Outcome Measures: Overall Survival [ Time Frame: 5 years ] Secondary Outcome Measures: Time to progression [ Time Frame: q 3 cycles ] Toxicity [ Time Frame: q cycle ]

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: 90206_Protocol.pdf

CRF: 90206_Annotated_Forms.pdf

DATA DICTIONARY: 90206_datasphere_FINAL.docx

DATA (ACTIVE ARM): final_analysis.sas7bdat

DATA (ACTIVE ARM): ae.sas7bdat