Evidence map›Paper›PMID 35123553›Full record

Trial reportTrials2022

Randomized phase III trial of intravenous and intraperitoneal paclitaxel with S-1 versus gemcitabine plus nab-paclitaxel for pancreatic ductal adenocarcinoma with peritoneal metastasis (SP study).

Tomohisa Yamamoto, Tsutomu Fujii, Satoshi Hirano, Fuyuhiko Motoi, Goro Honda, Kenichiro Uemura, Joji Kitayama, Michiaki Unno, Yasuhiro Kodera, Hiroki Yamaue and 9 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.5field-weighted citation impact, top 16% 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

11 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Oligometastatic disease in pancreatic cancer: is there a role for curative-intent surgery? A narrative review.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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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

19 authors at 12 institutions in 1 country.

Tomohisa YamamotoDepartment of Surgery, Kansai Medical University, 2-3-1, Shin-machi, Hirakata, Osaka, 573-1191, Japan.
Tsutomu FujiiDepartment of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama, Toyama, Japan.
Satoshi HiranoDepartment of Gastroenterological Surgery II, Hokkaido University Faculty of Medicine, Sapporo, Japan.
Fuyuhiko MotoiDepartment of Surgery I, Yamagata University, Yamagata, Japan.
Goro HondaDepartment of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, Tokyo, Japan.
Kenichiro UemuraDepartment of Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Joji KitayamaDepartment of Surgery, Division of Gastroenterological, General and Transplant Surgery, Jichi Medical University, Tochigi, Japan.
Michiaki UnnoDepartment of Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan.
Yasuhiro KoderaGastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Hiroki YamaueSecond Department of Surgery, Wakayama Medical University, School of Medicine, Wakayama, Japan.
Toshio ShimokawaClinical Study Support Center, Wakayama Medical University, School of Medicine, Wakayama, Japan.
Daisuke HashimotoDepartment of Surgery, Kansai Medical University, 2-3-1, Shin-machi, Hirakata, Osaka, 573-1191, Japan.
So YamakiDepartment of Surgery, Kansai Medical University, 2-3-1, Shin-machi, Hirakata, Osaka, 573-1191, Japan.
Hideyuki YoshitomiDepartment of General Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.
Fumihiko MiuraDepartment of Surgery, Teikyo University Hospital, Mizonokuchi, Kawasaki, Japan.
Hideki UenoHepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
Mitsugu SekimotoDepartment of Surgery, Kansai Medical University, 2-3-1, Shin-machi, Hirakata, Osaka, 573-1191, Japan.
Sohei SatoiDepartment of Surgery, Kansai Medical University, 2-3-1, Shin-machi, Hirakata, Osaka, 573-1191, Japan. satoi@hirakata.kmu.ac.jp.ORCID http://orcid.org/0000-0001-6527-5409
Study Group of Pancreatic Ductal Adenocarcinoma with Peritoneal Metastasis
Kansai Medical University · JPWakayama Medical University · JPChiba University · JPHiroshima University · JPHokkaido University · JPJichi Medical University · JPNagoya University · JPTeikyo University Hospital · JPTohoku University · JPTokyo Women's Medical University · JPUniversity of Toyama · JPYamagata University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The prognosis of pancreatic ductal carcinoma (PDAC) with peritoneal metastasis remains dismal. Systemic chemotherapy alone may not be effective, and the combination of intraperitoneal chemotherapy with systemic chemotherapy is expected to prolong the overall survival in patients with peritoneal metastasis. We have designed a randomized phase III trial to confirm the superiority of intravenous (i.v.) and intraperitoneal (i.p.) paclitaxel (PTX) with S-1 relative to gemcitabine plus nab-PTX (GnP), which is the current standard therapy for patients with metastatic PDAC. A total of 180 patients will be accrued from 30 institutions within 3 years. Patients will be randomly assigned in a 1:1 ratio to receive either i.v. and i.p. PTX with S-1 or GnP (target of 90 patients per group). The primary endpoint is overall survival; secondary endpoints are progression-free survival, response rate, proportion with negative peritoneal washing cytology during chemotherapy, proportion requiring conversion surgery, and adverse event profiles. Japan Registry of Clinical Trials jRCTs051180199 ( https://jrct.niph.go.jp/ ).

Indexed as

AdenocarcinomaCarcinoma, Pancreatic DuctalPancreatic NeoplasmsPeritoneal NeoplasmsAlbuminsAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineGemcitabineHumansPaclitaxel130-nm albumin-bound paclitaxelAlbuminsDeoxycytidineGemcitabinePaclitaxelIntraperitoneal PaclitaxelPancreatic ductal carcinomaPeritoneal deseminationPeritoneal metastasisRandomized phase3 trial

Identifiers

PMID35123553
PMCPMC8817533
OpenAlexW4225919013

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.