Evidence map›Paper›PMID 34446057›Full record

Trial reportTrials2021

Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine and nanoparticle albumin-bound paclitaxel combination therapy as neoadjuvant chemotherapy for resectable/borderline resectable pancreatic ductal adenocarcinoma (PDAC-GS/GA-rP2, CSGO-HBP-015).

Daisaku Yamada, Shogo Kobayashi, Hidenori Takahashi, Hirofumi Akita, Terumasa Yamada, Tadafumi Asaoka, Junzo Shimizu, Yutaka Takeda, Shigekazu Yokoyama, Masanori Tsujie and 11 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.1field-weighted citation impact, top 20% 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

10 citing papers in PubMed, 15 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

21 authors at 15 institutions in 1 country.

Daisaku YamadaDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Yamadaoka 2-2-E2, Suita, Osaka, 565-0871, Japan.ORCID http://orcid.org/0000-0002-6702-3800
Shogo KobayashiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Yamadaoka 2-2-E2, Suita, Osaka, 565-0871, Japan.
Hidenori TakahashiDepartment of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.
Hirofumi AkitaDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Yamadaoka 2-2-E2, Suita, Osaka, 565-0871, Japan.
Terumasa YamadaDepartment of Surgery, Higashiosaka City Medical Center, Higashiōsaka, Japan.
Tadafumi AsaokaDepartment of Gastroenterological Surgery, Osaka Police Hospital, Osaka, Japan.
Junzo ShimizuDepartment of Gastroenterological Surgery, Toyonaka Municipal Hospital, Toyonaka, Japan.
Yutaka TakedaDepartment of Gastroenterological Surgery, Kansai Rosai Hospital, Amagasaki, Japan.
Shigekazu YokoyamaDepartment of Gastroenterological Surgery, Hyogo Prefectural Nishinomiya Hospital, Nishinomiya, Japan.
Masanori TsujieDepartment of Gastroenterological Surgery, Osaka Rosai Hospital, Sakai, Japan.
Akira TomokuniDepartment of Gastroenterological Surgery, Osaka General Medical Center, Osaka, Japan.
Masahiro TanemuraDepartment of Gastroenterological Surgery, Rinku General Medical Center, Izumisano, Japan.
Osakuni MorimotoDepartment of Surgery, Japan Community Health Care Organization Osaka Hospital, Osaka, Japan.
Masahiro MurakamiDepartment of Gastroenterological Surgery, Itami City Hospital, Itami, Japan.
Yongkook KimDepartment of Surgery, Kaizuka City Hospital, Kaizuka, Japan.
Shin NakahiraDepartment of Surgery, Sakai City Medical Center, Sakai, Japan.
Naoki HamaDepartment of Surgery, Ikeda City Hospital, Ikeda, Japan.
Keishi SugimotoDepartment of Surgery, Minoh City Hospital, Minoh, Japan.
Kazuhiko HashimotoDepartment of Surgery, Kindai University Nara Hospital, Ikoma, Japan.
Yuichiro DokiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Yamadaoka 2-2-E2, Suita, Osaka, 565-0871, Japan.
Hidetoshi EguchiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Yamadaoka 2-2-E2, Suita, Osaka, 565-0871, Japan. heguchi@gesurg.med.osaka-u.ac.jp.
The University of Osaka · JPHyogo Prefectural Nishinomiya Hospital · JPIkeda Municipal Hospital · JPItami City Hospital · JPKansai Rosai Hospital · JPKindai University · JPMinoh City Hospital · JPOsaka Hospital · JPOsaka International Cancer Institute · JPOsaka Police Hospital · JPOsaka Prefectural Medical Center · JPOsaka Rosai Hospital · JPSakai Municipal Hospital · JPTakarazuka City Hospital · JPToyonaka Municipal Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPancreatic ductal adenocarcinoma (PDAC) is a lethal disease, and multimodal strategies, such as surgery plus neoadjuvant chemotherapy (NAC)/adjuvant chemotherapy, have been attempted to improve survival in patients with localized PDAC. To date, there is one prospective study providing evidence for the superiority of a neoadjuvant strategy over upfront surgery for localized PDAC. However, which NAC regimen is optimal remains unclear.

methodsA randomized, exploratory trial is performed to examine the clinical benefits of two chemotherapy regimens, gemcitabine plus S-1 (GS) and gemcitabine plus nab-paclitaxel (GA), as NAC for patients with planned PDAC resection. Patients are enrolled after the diagnosis of resectable or borderline resectable PDAC. They are randomly assigned to either NAC regimen. Adjuvant chemotherapy after curative resection is highly recommended for 6 months in both arms. The primary endpoint is tumor progression-free survival time, and secondary endpoints include the rate of curative resection, the completion rate of protocol therapy, the recurrence type, the overall survival time, and safety. The target sample size is set as at least 100. DISCUSSION: This study is the first randomized phase II study comparing GS combination therapy with GA combination therapy as NAC for localized pancreatic cancer.

trial registrationUMIN Clinical Trials Registry UMIN000021484 . This trial began in April 2016.

Indexed as

AdenocarcinomaNanoparticlesPancreatic NeoplasmsAlbumin-Bound PaclitaxelAlbuminsAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineGemcitabineGTP-Binding ProteinsHumansMembrane ProteinsNeoadjuvant TherapyPaclitaxelProspective Studies130-nm albumin-bound paclitaxelAlbumin-Bound PaclitaxelAlbuminsDeoxycytidineGemcitabineGTP-Binding ProteinsMembrane ProteinsPaclitaxelRP2 protein, humanGemcitabine plus nab-paclitaxelGemcitabine plus S-1Neoadjuvant chemotherapyPancreatic cancer

Identifiers

PMID34446057
PMCPMC8394677
OpenAlexW3194704051

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.