Efficacy and safety of cytokines versus first-line sunitinib and second-line axitinib for patients with metastatic renal cell carcinoma (ESCAPE study): A study protocol for phase III randomized sequential open-label study

Yoshifumi Kadono, Hiroyuki Konaka, Kouji Izumi, Satoshi Anai, Kiyohide Fujimoto, Kei Ishibashi, Noriyasu Kawai, Taku Kato, Akinori Iba, Naoya Masumori, Kenichi Yoshimura, Atsushiu Mizokami

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1 Citation (Scopus)

Abstract

Appropriate protocol for the sequential treatment of metastatic renal cell carcinoma (mRCC) has not been established yet. Some mRCC cases with favorable risk were reported to achieve complete remission and durable response using interferon alfa (IFNα) + low dose interleukin-2 (IL-2). Cytokine therapies may be suitable for some patients with mRCC as first-line therapy. The present study is a phase III, investigator-initiated, multicenter, prospective randomized controlled trial investigating patients with low and intermediate risk mRCC classified by Memorial Sloan-Kettering Cancer Center risk criteria to evaluate the efficacy and safety of sequential treatment with cytokine (IFNα + IL-2) as first-line and axitinib as second-line therapy versus sequential treatment with sunitinib as first-line and axitinib as second-line therapy, which is the current standard treatment for patients with favorable risk. The target sample size was set at 72 patients per group (total 144 cases). The study duration is 7 years, and the duration for recruitment is 4 years. Our expectation of this trial is to clarify first- and second-line sequential treatment for mRCC better, especially in patients with favorable risk and some with intermediate risk. The results of this trial will certainly contribute to new information for the strategy of first- and second-line sequential treatment for mRCC. Trial registration: University hospital Medical Information Network (UMIN) Center identifier UMIN 000012522.

Original languageEnglish
Article number100403
JournalContemporary Clinical Trials Communications
Volume15
DOIs
Publication statusPublished - 09-2019
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Pharmacology

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