Evidence map›Paper›PMID 36890471›Full record

ArticleBMC cancer2023

Protocol for the 2ND-STEP study, Japan Clinical Oncology Group study JCOG1802: a randomized phase II trial of second-line treatment for advanced soft tissue sarcoma comparing trabectedin, eribulin and pazopanib.

Makoto Endo, Tomoko Kataoka, Toshifumi Fujiwara, Satoshi Tsukushi, Masanobu Takahashi, Eisuke Kobayashi, Yoko Yamada, Takaaki Tanaka, Yutaka Nezu, Hiroaki Hiraga and 16 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.6field-weighted citation impact, top 17% 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

6 citing papers in PubMed, 6 citations in OpenAlex.

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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

26 authors at 18 institutions in 1 country.

Makoto Endo *Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Tomoko Kataoka *JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Toshifumi FujiwaraDepartment of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Satoshi TsukushiDepartment of Orthopaedic Surgery, Aichi Cancer Center, Nagoya, Japan.
Masanobu TakahashiDepartment of Clinical Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Eisuke KobayashiDepartment of Musculoskeletal Oncology, National Cancer Center Hospital, Tokyo, Japan.
Yoko YamadaDepartment of Breast and Medical Oncology, Saitama Cancer Center, Saitama, Japan.
Takaaki TanakaDepartment of Orthopaedic Surgery, Fukui University School of Medicine, Fukui, Japan.
Yutaka NezuDepartment of Musculoskeletal Tumor Surgery, Kanagawa Cancer Center, Yokohama, Japan.
Hiroaki HiragaDepartment of Musculoskeletal Oncology, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.
Junji WasaDivision of Orthopaedic Oncology, Shizuoka Cancer Center, Nagaizumi, Japan.
Akihito NaganoDepartment of Orthopaedic Surgery, Gifu University School of Medicine, Gifu, Japan.
Kenji NakanoDepartment of Medical Oncology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Robert NakayamaDepartment of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan.
Tetsuya HamadaDepartment of Orthopaedic Surgery, Kurume University School of Medicine, Kurume, Japan.
Masanori KawanoDepartment of Orthopaedic Surgery, Faculty of Medicine, Oita University, 1-1 Idaigaoka, Yufu City Oita, Hasama, 879-5593, Japan.
Tomoaki TorigoeDepartment of Orthopaedic Oncology and Surgery, Saitama Medical University International Medical Center, Hidaka, Japan.
Akio SakamotoDepartment of Orthopaedic Surgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Kunihiro AsanumaDepartment of Orthopaedic Surgery, Mie University Graduate School of Medicine, Tsu, Japan.
Takeshi MoriiDepartment of Orthopaedic Surgery, Faculty of Medicine, Kyorin University, Mitaka, Japan.
Ryunosuke MachidaJCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Yuta SekinoJCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Haruhiko FukudaJCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Yoshinao OdaDepartment of Anatomic Pathology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Toshifumi OzakiDepartment of Orthopaedic Surgery, Science of Functional Recovery and Reconstruction, Faculty of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, Okayama, Japan.
Kazuhiro TanakaDepartment of Orthopaedic Surgery, Faculty of Medicine, Oita University, 1-1 Idaigaoka, Yufu City Oita, Hasama, 879-5593, Japan. ktanaka@oita-u.ac.jp.
Kyushu University · JPOita University · JPAichi Cancer Center · JPGifu University · JPJapanese Foundation For Cancer Research · JPKanagawa Prefectural Hospital Organization · JPKeio University · JPKurume University · JPKyorin University · JPKyoto University · JPMie University · JPOkayama University · JPSaitama Cancer Center · JPSaitama Medical University · JPSapporo National Hospital · JPShizuoka Cancer Center · JPTohoku University · JPUniversity of Fukui · JP

Funding

Japan Agency for Medical Research and Development JP21ck0106507National Cancer Center Research and Development Fund 2020-J-3
6 · The paper itself

Abstract

backgroundSoft tissue sarcomas (STS) are a rare type of malignancy comprising a variety of histological diagnoses. Chemotherapy constitutes the standard treatment for advanced STS. Doxorubicin-based regimens, which include the administration of doxorubicin alone or in combination with ifosfamide or dacarbazine, are widely accepted as first-line chemotherapy for advanced STS. Trabectedin, eribulin, pazopanib, and gemcitabine plus docetaxel (GD), which is the empirical standard therapy in Japan, are major candidates for second-line chemotherapy for advanced STS, although clear evidence of the superiority of any one regimen is lacking. The Bone and Soft Tissue Tumor Study Group of the Japan Clinical Oncology Group (JCOG) conducts this trial to select the most promising regimen among trabectedin, eribulin, and pazopanib for comparison with GD as the test arm regimen in a future phase III trial of second-line treatment for patients with advanced STS.

methodsThe JCOG1802 study is a multicenter, selection design, randomized phase II trial comparing trabectedin (1.2 mg/m DISCUSSION: This is the first randomized trial to evaluate trabectedin, eribulin, and pazopanib as second-line therapies for advanced STS. We endeavor to perform a subsequent phase III trial comparing the best regimen selected by this study (JCOG1802) with GD.

trial registrationThis study was registered with the Japan Registry of Clinical Trials ( jRCTs031190152 ) on December 5, 2019.

Indexed as

Liposarcoma, MyxoidSarcomaSoft Tissue NeoplasmsAdultClinical Trials, Phase II as TopicDocetaxelDoxorubicinFuransGemcitabineHumansIndazolesJapanKetonesMedical OncologyMulticenter Studies as TopicPolyether PolyketidesDocetaxelDoxorubicineribulinFuransGemcitabineIndazolesKetonespazopanibPolyether PolyketidesPyrimidinesSulfonamidesTrabectedinAdvanced stageChemotherapyEribulinMetastaticPazopanibRandomized phase II trialSecond-lineSoft tissue sarcomaTrabectedinUnresectable

Identifiers

PMID36890471
PMCPMC9996999
OpenAlexW4323546413

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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.