Eligibility Criteria and Endpoints in Metastatic Renal Cell Carcinoma Trials.

ABSTRACT:

Objectives

Treatments for metastatic renal cell carcinoma (mRCC) are often compared across trials, but trial eligibility criteria and endpoints differ. In an effort to better align trials, the Definition for the Assessment of Time to event Endpoints in CANcer trials (DATECAN) project published recommendations in 2015 to be used in mRCC clinical trial design. We analyzed mRCC trial criteria to determine if DATECAN's recommendations were followed.

Materials and methods

We compared eligibility criteria across 29 phase 3 mRCC trials conducted between 2003 and 2019. We then evaluated endpoints used in 10 phase 3 trials activated between 2015 and 2019 to determine their compliance with DATECAN's recommendations.

Results

Among the 29 trials, performance status, renal functio

SUBMITTER: Wong SE 

PROVIDER: S-EPMC7515769 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature