Evidence map›Paper›PMID 31533662›Full record

Trial reportBMC cancer2019

Postoperative XELOX therapy for patients with curatively resected high-risk stage II and stage III rectal cancer without preoperative chemoradiation: a prospective, multicenter, open-label, single-arm phase II study.

Tsunekazu Mizushima, Masataka Ikeda, Takeshi Kato, Atsuyo Ikeda, Junichi Nishimura, Taishi Hata, Chu Matsuda, Taroh Satoh, Masaki Mori, Yuichiro Doki

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Computational Tactics for Precision Cancer Network Biology.International journal of molecular sciences · 2022
    Review
  6. Article
  7. Article
  8. Article
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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.

Tsunekazu MizushimaMulti-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan. tmizushima@gesurg.med.osaka-u.ac.jp.ORCID http://orcid.org/0000-0002-0825-6823
Masataka IkedaMulti-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan.
Takeshi KatoMulti-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan.
Atsuyo IkedaMulti-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan.
Junichi NishimuraMulti-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan.
Taishi HataMulti-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan.
Chu MatsudaMulti-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan.
Taroh SatohMulti-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan.
Masaki MoriMulti-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan.
Yuichiro DokiMulti-Center Clinical Study Group of Osaka University, Colorectal Group (MCSGO), 2-2 E2 Yamadaoka, Suita, Osaka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreoperative 5-FU-based chemoradiation is currently a standard treatment for advanced rectal cancer, particularly in Western countries. Although it reduced the local recurrence, it could not necessarily improve overall survival. Furthermore, it can also produce adverse effects and long-term sphincter function deficiency. Adjuvant oxaliplatin plus capecitabine (XELOX) is a recommended regimen for patients with curatively resected colon cancer. However, the efficacy of postoperative adjuvant therapy for rectal cancer patients who have not undergone preoperative chemoradiation remains unknown. We aimed to evaluate the efficacy of surgery and postoperative XELOX without preoperative chemoradiation for treating rectal cancer.

methodsWe performed a prospective, multicenter, open-label, single arm phase II study. Patients with curatively resected high-risk stage II and stage III rectal cancer who had not undergone preoperative therapy were treated with a 120 min intravenous infusion of oxaliplatin (130 mg/m

resultsBetween August 2012 and June 2015, 60 men and 47 women with a median age was 63 years (range: 29-77 years) were enrolled. Ninety-three patients had Eastern Cooperative Oncology Group performance status scores of '0' and 14 had scores of '1'. Tumors were located in the upper and lower rectums in 54 and 48 patients, respectively; 8 patients had stage II disease and 99 had stage III. The 3-year DFS was 70.1% (95% confidence interval, 60.8-78.0%) and 33 patients (31%) experienced recurrence, most commonly in the lung (16 patients) followed by local recurrence (9) and hepatic recurrence (7).

conclusionsPostoperative XELOX without preoperative chemoradiation is effective for rectal cancer and provides adequate 3-year DFS prospects.

trial registrationThis clinical trial was registered in the University Hospital Medical Information Network registry system as UMIN000008634 at Aug 06, 2012.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCapecitabineChemotherapy, AdjuvantDeoxycytidineDisease-Free SurvivalFemaleFluorouracilHumansMaleMiddle AgedNeoplasm StagingOxaliplatinOxaloacetatesProspective StudiesCapecitabineDeoxycytidineFluorouracilOxaliplatinOxaloacetatesAdjuvant chemotherapyCapecitabineOxaliplatinRectal cancerXELOX

Identifiers

PMID31533662
PMCPMC6751668

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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.