Evidence map›Paper›PMID 31312749›Full record

ArticleContemporary clinical trials communications2019

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 and 2 more

Open access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 8 institutions in 1 country.

Yoshifumi KadonoDepartment of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.
Hiroyuki KonakaDepartment of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.
Kouji IzumiDepartment of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.
Satoshi AnaiDepartment of Urology, Nara Medical University, Kashihara-Shi, Nara, Japan.
Kiyohide FujimotoDepartment of Urology, Nara Medical University, Kashihara-Shi, Nara, Japan.
Kei IshibashiDepartment of Urology, Fukushima Medical University, Fukushima, Japan.
Noriyasu KawaiDepartment of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Taku KatoDepartment of Urology, Gifu University Graduate School of Medicine, Gifu, Japan.
Akinori IbaDepartment of Urology, Wakayama Medical University, Wakayama, Japan.
Naoya MasumoriDepartment of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Kenichi YoshimuraInnovative Clinical Research Center (iCREK), Kanazawa University Hospital, Kanazawa, Japan.
Atsushiu MizokamiDepartment of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.
Kanazawa University · JPNara Medical University · JPFukushima Medical University · JPGifu University · JPKanazawa University Hospital · JPNagoya City University · JPSapporo Medical University · JPWakayama Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 registrationUniversity hospital Medical Information Network (UMIN) Center identifier UMIN 000012522.

Indexed as

AxitinibCytokineInterferon alfaInterleukin-2Metastatic renal cell carcinomaSunitinib

Identifiers

PMID31312749
PMCPMC6610625
OpenAlexW2954954143

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.