Evidence map›Paper›PMID 29310611›Full record

Trial reportBMC cancer2018

Study protocol of a phase II clinical trial (KSCC1501A) examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy.

Hiroshi Saeki, Yasunori Emi, Eiji Oki, Shoji Tokunaga, Yoshihiro Kakeji, Yoshito Akagi, Hideo Baba, Eishi Baba, Yoshihiko Maehara, Kyushu Study group of Clinical Cancer (KSCC)

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Safety and efficacy of S-1 plus oxaliplatin 130 mg/mInternational journal of clinical oncology · 2021
    Trial
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

10 authors.

Hiroshi SaekiDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. h-saeki@surg2.med.kyushu-u.ac.jp.
Yasunori EmiDepartment of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
Eiji OkiDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Shoji TokunagaMedical Information Center, Kyushu University Hospital, Fukuoka, Japan.
Yoshihiro KakejiDivision of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, Kobe, Japan.
Yoshito AkagiDepartment of Surgery, Kurume University School of Medicine, Fukuoka, Japan.
Hideo BabaDepartment of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
Eishi BabaDepartment of Comprehensive Clinical Oncology, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan.
Yoshihiko MaeharaDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Kyushu Study group of Clinical Cancer (KSCC)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOxaliplatin + S-1 is a recognized treatment regimen in Japan, but there are no Japanese clinical data on an oxaliplatin dose of 130 mg/m METHODS/

designThe primary endpoint of this trial will be the response rate, and the secondary endpoints will be the safety profile of oxaliplatin + S-1, progression-free survival, the response rate in subjects under the age of 75, overall survival, time to treatment failure, duration of treatment, time to failure of strategy, and dose intensity. The threshold response rate is 45% and the expected response rate is 60%. Assuming that a one-tailed score test will be performed with an α of 0.05, 68 patients are needed to ensure a statistical power of 80%. Planned enrollment is 70 subjects and the total duration of this trial is expected to be 3 years. DISCUSSION: Since replacing cisplatin with oxaliplatin should provide the same level of therapeutic efficacy while limiting adverse events and simplifying treatment, oxaliplatin + S-1 may be increasingly used to treat gastric cancer in Japan. Verifying the efficacy and safety of oxaliplatin + S-1 with an oxaliplatin dose of 130 mg is an important task that the current trial has set out to achieve.

trial registrationThe protocol was registered at the website of the University Hospital Medical Information Network (UMIN), Japan (protocol ID UMIN000017550) on May 29, 2015. The details are available at the following web address: http://www.umin.ac.jp/ctr/ .

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalDrug CombinationsDrug-Related Side Effects and Adverse ReactionsErb-b2 Receptor Tyrosine KinasesFemaleHumansJapanMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalOrganoplatinum CompoundsOxaliplatinDrug CombinationsERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesOrganoplatinum CompoundsOxaliplatinOxonic AcidS 1 (combination)TegafurFirst-line chemotherapyJapanese patientsMetastatic gastric cancerOxaliplatinS-1

Identifiers

PMID29310611
PMCPMC5759242

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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.