Evidence map›Paper›PMID 39500618›Full record

ArticleJapanese journal of clinical oncology2025

Study protocol: randomized phase III trial of neo-adjuvant and adjuvant chemotherapy vs. immediate surgery and adjuvant chemotherapy for localized soft tissue sarcoma: Japan Clinical Oncology Group study JCOG2102 (NACLESS).

Yuki Funauchi, Satoshi Tsukushi, Hiroaki Hiraga, Akio Sakamoto, Toshiyuki Kunisada, Akihito Nagano, Koji Hiraoka, Kazutaka Kikuta, Tsukasa Yonemoto, Keisuke Ae and 10 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Japanese journal of clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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. Article
  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

20 authors.

Yuki FunauchiDepartment of Orthopaedic Surgery, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.ORCID 0000-0001-7031-672X
Satoshi TsukushiDivision of Orthopaedic Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.ORCID 0000-0002-2181-0702
Hiroaki HiragaDepartment of Musculoskeletal Oncology, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.ORCID 0000-0003-1825-1070
Akio SakamotoDepartment of Orthopaedic Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Toshiyuki KunisadaDepartment of Orthopaedic Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.ORCID 0000-0002-1775-850X
Akihito NaganoDepartment of Orthopaedic Surgery, Gifu University Graduate School of Medicine, Gifu, Japan.ORCID 0000-0003-0261-480X
Koji HiraokaDepartment of Orthopedic Surgery, Kurume University School of Medicine, Kurume City, Fukuoka, Japan.
Kazutaka KikutaDivision of Musculoskeletal Oncology and Orthopaedic Surgery, Tochigi Cancer Center, Tochigi, Japan.
Tsukasa YonemotoDivision of Orthopaedic Surgery, Chiba Cancer Center, Chiba, Japan.
Keisuke AeDepartment of Orthopaedic Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Akira KawaiDivision of Musculoskeletal Oncology and Rehabilitation Medicine, National Cancer Center Hospital, Tokyo, Japan.
Makoto EndoDepartment of Orthopaedic Surgery, Kyushu University, Fukuoka, Japan.ORCID 0000-0002-7956-2190
Yusuke SanoJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0001-7753-8712
Ryunosuke MachidaJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Tetsuya SekitaJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Haruhiko FukudaJapan Clinical Oncology Group 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, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Kazuhiro TanakaDepartment of Advanced Medical Sciences, Oita University Faculty of Medicine, Oita, Japan.ORCID 0000-0002-5138-8952
JCOG Bone Soft Tissue Tumor Study Group

Funding

National Cancer Center Research and Development Fund 2020-J-3
6 · The paper itself

Abstract

The optimal timing of surgery and the number of courses of perioperative chemotherapy for high-risk soft tissue sarcoma patients are still controversial. Tumour growth during neoadjuvant chemotherapy led to limb amputation in some patients. This study aims to confirm the non-inferiority of surgery and three courses of adjuvant chemotherapy with adriamycin (30 mg/m2, days 1 and 2) plus ifosfamide (2 g/m2, days 1-5) compared with our standard treatment of three courses of neoadjuvant chemotherapy and surgery followed by two courses of adjuvant chemotherapy with adriamycin plus ifosfamide for localized high-risk soft tissue sarcoma patients. This is a multi-center, two-arm, open-label, randomized phase III trial. The primary aim is to confirm the non-inferiority in overall survival (margin: hazard ratio of 1.61). This is the first randomized controlled trial to compare neoadjuvant chemotherapy and immediate surgery for soft tissue sarcoma. This trial was initiated on 16 November 2022 and registered with the Japan Clinical Trials Registry (jRCTs031220446).

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsNeoadjuvant TherapySarcomaChemotherapy, AdjuvantClinical Trials, Phase III as TopicDoxorubicinEquivalence Trials as TopicFemaleHumansIfosfamideJapanMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicDoxorubicinIfosfamideadjuvant chemotherapyneoadjuvant chemotherapyrandomized controlled trialsoft tissue sarcomasurgery

Identifiers

PMID39500618
PMCPMC11882499

What OpenQuestion holds

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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.