Evidence map›Paper›PMID 33402130›Full record

Trial reportBMC cancer2021

Randomized phase II study comparing the efficacy and safety of SOX versus mFOLFOX6 as neoadjuvant chemotherapy without radiotherapy for locally advanced rectal cancer (KSCC1301).

Keisuke Miwa, Eiji Oki, Masanobu Enomoto, Keisuke Ihara, Koji Ando, Fumihiko Fujita, Masahiro Tominaga, Shinichiro Mori, Goro Nakayama, Mototsugu Shimokawa and 4 more

Open access · goldAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 28% 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

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. 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

14 authors at 11 institutions in 1 country.

Keisuke MiwaMultidisciplinary Treatment Cancer Center, Kurume University Hospital, Kurume, Japan.
Eiji OkiDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582, Japan. okieiji@surg2.med.kyushu-u.ac.jp.ORCID http://orcid.org/0000-0002-9763-9366
Masanobu EnomotoGastrointestinal and Pediatric Surgery, Tokyo Medical University, Tokyo, Japan.
Keisuke IharaFirst Department of Surgery, Dokkyo Medical University, Tochigi, Japan.
Koji AndoDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582, Japan.
Fumihiko FujitaDepartment of Surgery, Kurume University School of Medicine, Kurume, Japan.
Masahiro TominagaDepartment of Gastroenterological Surgery, Hyogo Cancer Center, Nishinomiya, Japan.
Shinichiro MoriDepartment of Digestive Surgery, Breast and Thyroid Surgery, Kagoshima University, Kagoshima, Japan.
Goro NakayamaDepartment of Gastroenterological Surgery, Graduate School of Medicine, Nagoya University, Nagoya, Japan.
Mototsugu ShimokawaCancer Biostatistics Laboratory, Clinical Research Institute, National Hospital Organization Kyusyu Cancer Center, Fukuoka, Japan.
Hiroshi SaekiDepartment of Gastroenterological Surgery, Gunma University Graduate School of Medicine, Maebashi, Japan.
Hideo BabaDepartment of Gastroenterological Surgery, Kumamoto University Graduate School of Medicine, Kumamoto, Japan.
Masaki MoriDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582, Japan.
Yoshito AkagiDepartment of Surgery, Kurume University School of Medicine, Kurume, Japan.
Kyushu University · JPKurume University · JPDokkyo Medical University · JPGunma University · JPHyogo Prefectural Cancer Center · JPKagoshima University · JPKumamoto University · JPKurume University Hospital · JPNagoya University · JPTokyo Medical University · JPYamaguchi University · JP

Funding

Taiho Pharmaceutical KSCC1301
6 · The paper itself

Abstract

backgroundPreoperative chemoradiotherapy (CRT), the current standard of care for locally advanced rectal cancer (LARC), is associated with many radiotherapy (RT)-related side effects. We aimed to evaluate whether S-1 and oxaliplatin (SOX) or folinic acid, 5-FU, and oxaliplatin (mFOLFOX6) can be as effective as neoadjuvant chemotherapy (NAC) regimens for LARC without RT.

methodsPatients with untreated resectable LARC were randomly assigned to receive SOX or mFOLFOX6. The NAC protocol period was 3 months. The primary endpoint was 3-year disease-free survival (DFS), and the secondary endpoints included pathological effects, surgical completion rate, 3-year survival, and safety.

resultsFrom September 2013 to October 2015, 56 and 54 patients were enrolled in the SOX and mFOLFOX6 arms, respectively. The 3-year DFS rates were 69.4% (95% confidence interval [CI] 54.9-83.6) and 73.4% (95% CI 58.7-83.6) in the SOX and mFOLFOX6 arms, respectively; no significant differences were found between the arms (log-rank test; P = 0.5315, hazard ratio: 0.808, 95% CI 0.414-1.578). The 3-year survival rates were 92.3 and 91.8% in the SOX and mFOLFOX6 arms, respectively. The surgical completion rate was 98.1% overall, 100% in the SOX arm, and 96.0% in the mFOLFOX6 arm. The incidences of pathological response rates ≥grade 1b were 41.5 and 43.8% in the SOX and mFOLFOX6 arms, respectively. Both treatments were manageable and tolerable.

conclusionWe demonstrated the effectiveness and safety of SOX and mFOLFOX6, both of which may be new neoadjuvant treatment candidates in previously untreated LARC cases.

trial registrationDate of enrolment of the first participant to the trial: 3rd Oct 2013; This study was registered in the UMIN clinical trials registry on 14th Aug, 2013. (Prospectively registered, UMIN-CTR number UMIN000011486). https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&recptno=R000013441&language=J.

Indexed as

AdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsChemotherapy, AdjuvantDrug CombinationsFemaleFluorouracilFollow-Up StudiesHumansLeucovorinMaleMiddle AgedNeoadjuvant TherapyOxaliplatinOxonic AcidDrug CombinationsFluorouracilLeucovorinOxaliplatinOxonic AcidS 1 (combination)TegafurChemoradiotherapymFOLFOX6Neoadjuvant chemotherapyRectal cancerSOX

Identifiers

PMID33402130
PMCPMC7786922
OpenAlexW3120357720

What OpenQuestion holds

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LicenceCC BY
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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.