Evidence map›Paper›PMID 33715077›Full record

Trial reportInternational journal of colorectal disease2021

Randomized phase II study of tegafur-uracil/leucovorin versus tegafur-uracil/leucovorin plus oxaliplatin after curative resection of high-risk stage II/III colorectal cancer (SOAC-1101 trial).

Chihiro Kosugi, Keiji Koda, Nobuhiro Takiguchi, Satoru Takaishi, Hideaki Miyauchi, Nobuo Hirayama, Yukihiro Nomura, Eisuke Kondo, Yohei Kawasaki, Yoshihito Ozawa and 1 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of colorectal disease, 2021. 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
0.2field-weighted citation impact, top 48% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

11 authors at 7 institutions in 1 country.

Chihiro KosugiDepartment of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan. ckosugi0126@yahoo.co.jp.ORCID http://orcid.org/0000-0003-3719-6425
Keiji KodaDepartment of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan.
Nobuhiro TakiguchiDivision of Surgery, Chiba Cancer Center, Chiba, Japan.
Satoru TakaishiDepartment of Surgery, Seikei-kai Chiba Medical Center, Chiba, Japan.
Hideaki MiyauchiDepartment of Frontier Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.
Nobuo HirayamaDepartment of Surgery, Kumagaya General Hospital, Kumagaya, Saitama, Japan.
Yukihiro NomuraDepartment of Surgery, Asahi General Hospital, Asahi, Chiba, Japan.
Eisuke KondoDepartment of Surgery, Japanese Red Cross Narita Hospital, Narita, Chiba, Japan.
Yohei KawasakiBiostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.
Yoshihito OzawaBiostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.
Hisahiro MatsubaraDepartment of Frontier Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.
Teikyo University Chiba Medical Center · JPChiba University · JPChiba University Hospital · JPAsahi General Hospital · JPChiba Cancer Center · JPJapanese Red Cross Narita Hospital · JPSaitama Prefectural Kumagaya Girls High School · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis randomized phase II trial compared tegafur-uracil/leucovorin (UFT/LV) plus oxaliplatin (TEGAFOX) to UFT/LV as adjuvant chemotherapy for patients with high-risk stage II/III colorectal cancer.

methodsFrom 2010 to April 2015, 159 patients who underwent curative resection were randomly assigned to receive TEGAFOX (85 mg/m

resultsThe 3-year disease-free survival rate was 84.2% in the TEGAFOX arm, versus 62.1% for UFT/LV. The stratified hazard ratio for disease-free survival for TEGAFOX compared to UFT/LV was 0.338 (P < 0.01). The incidence of any-grade adverse events was significantly higher in the TEGAFOX arm (96.1%) than in the UFT/LV arm (76.6%; P < 0.01). The rates of any-grade neutropenia, thrombocytopenia, aspartate aminotransferase/alanine aminotransferase elevation, and peripheral sensory neuropathy were higher in the TEGAFOX group, whereas the incidence of grade ≥ 3 adverse events did not differ between the groups.

conclusionsTEGAFOX is an additional adjuvant chemotherapy option for high-risk stage II/III colorectal cancer.

trial registrationUMIN ID: 000007696, date of registration: April 10, 2012.

Indexed as

Colorectal NeoplasmsTegafurAntineoplastic Combined Chemotherapy ProtocolsHumansLeucovorinOxaliplatinUracilLeucovorinOxaliplatinTegafurUracilColorectal cancerHigh-risk stage IIStage IIITEGAFOXUFT/LV

Identifiers

PMID33715077
OpenAlexW3137316326

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.