Evidence map›Paper›PMID 23763511›Full record

Trial reportCancer science2013

Randomized phase II study of gemcitabine plus S-1 versus S-1 in advanced biliary tract cancer: a Japan Clinical Oncology Group trial (JCOG 0805).

Chigusa Morizane, Takuji Okusaka, Junki Mizusawa, Atsuo Takashima, Makoto Ueno, Masafumi Ikeda, Yasuo Hamamoto, Hiroshi Ishii, Narikazu Boku, Junji Furuse

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer science, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 55 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 8 pooled it
10.2field-weighted citation impact, top 1% 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.

NCT02146703 phase2completednot on this map

Phase II Trial of Gemcitabine and S-1 for Patients With Advanced Biliary Tract Cancer

TypeinterventionalSponsorHallym University Medical CenterRan2005 to 2013Enrolled38ConditionsBiliary Tract NeoplasmArmsGemcitabine, and S-1
NCT02425137 phase2completednot on this mapstarted 2015, after this paper: background citation

A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer

TypeinterventionalSponsorTTY BiopharmRan2015 to 2017Enrolled51ConditionsAdvanced Biliary Tract Cancer(BTC)ArmsS-1/Gemcitabine
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 8 syntheses or guidelines pooled it, 101 citations in OpenAlex.

  1. Pooled it
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  5. Gemcitabine-based chemotherapy for advanced biliary tract carcinomas.The Cochrane database of systematic reviews · 2018
    Pooled it
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  11. Multicentre, phase II study of gemcitabine and S-1 in patients with advanced biliary tract cancer: TG1308 study.Liver international : official journal of the International Association for the Study of the Liver · 2020
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  14. Concurrent radiotherapy with S-1 plus cisplatin versus concurrent radiotherapy with cisplatin alone for the treatment of locally advanced cervical carcinoma: a pilot randomised controlled trial.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2016
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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

10 authors at 8 institutions in 1 country.

Chigusa MorizaneHepatobiliary and Pancreatic Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Takuji Okusaka
Junki Mizusawa
Atsuo Takashima
Makoto Ueno
Masafumi Ikeda
Yasuo Hamamoto
Hiroshi Ishii
Narikazu Boku
Junji Furuse
Japan Clinical Cancer Research Organization · JPNational Cancer Centre Japan · JPKanagawa Prefectural Hospital Organization · JPKyorin University · JPNational Cancer Center Hospital East · JPSt. Marianna University School of Medicine · JPThe Cancer Institute Hospital · JPTochigi Cancer Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The oral fluoropyrimidine, S-1, combined with or without gemcitabine is considered to be a promising agent for treating advanced biliary tract cancer; gemcitabine plus cisplatin is the current standard regimen. This randomized phase II trial was designed to evaluate the safety and efficacy of two regimens: gemcitabine plus S-1 (GS) (gemcitabine: 1000 mg/m(2) , day 1 and day 8; S-1: 60 mg/m(2) , twice daily on days 1-14, repeated every 3 weeks); and S-1 (80 mg/m(2) , days 1-28, given orally twice daily for 4 weeks, followed by a 2-week rest, repeated every 6 weeks). The regimen with a higher 1-year survival would be selected for a subsequent phase III trial. Between February 2009 and April 2010, 101 patients were randomized. For the GS (n = 51) and S-1 (n = 50) arms, the 1-year survival was 52.9% (95% confidence interval, 38.5-65.5) and 40.0% (95% confidence interval, 26.5-53.1), and the median survival times were 12.5 and 9.0 months, respectively. Grade 3/4 hematological toxicities were more frequent in the GS arm (leucocytes 29.4%, neutrophils 60.8%, hemoglobin 11.8%, platelets 11.8%) than in the S-1 arm (leucocytes 2.0%, neutrophils 4.0%, hemoglobin 4.0%, platelets 4.0%). Although two treatment-related deaths occurred in the GS arm, all other grade 3/4 non-hematological toxicities were reversible. In conclusion, GS was considered to be more promising and was selected as the test regimen for a subsequent phase III trial comparing GS with gemcitabine plus cisplatin combination therapy. This study was registered at the UMIN Clinical Trials Registry as UMIN 000001685 (http://www.umin.ac.jp/ctr/index.htm).

Indexed as

AdultAgedAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsDeoxycytidineDrug CombinationsFemaleGemcitabineHumansJapanMaleMiddle AgedOxonic AcidTegafurAntimetabolites, AntineoplasticDeoxycytidineDrug CombinationsGemcitabineOxonic AcidS 1 (combination)Tegafur

Identifiers

PMID23763511
PMCPMC7657216
OpenAlexW1963537359

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.