Evidence map›Paper›PMID 24839048›Full record

ArticleInternational journal of clinical oncology2015

A phase I trial of preoperative S-1 in combination with oxaliplatin and pelvic radiation for lower rectal cancer with T4 and lateral pelvic lymph node metastasis.

Masayuki Ohue, Tetsuya Hamaguchi, Yoshinori Ito, Daisuke Sakai, Shingo Noura, Yusuke Kinugasa, Shin Fujita, Yasuhiro Shimada, Norio Saito, Yoshihiro Moriya

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Publisher
In one paragraph

Article in International journal of clinical oncology, 2015. 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
0.1field-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, 1 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

10 authors at 7 institutions in 2 countries.

Masayuki OhueDivision of Colon and Rectal Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan, ohue-ma@mc.pref.osaka.jp.
Tetsuya Hamaguchi
Yoshinori Ito
Daisuke Sakai
Shingo Noura
Yusuke Kinugasa
Shin Fujita
Yasuhiro Shimada
Norio Saito
Yoshihiro Moriya
National Cancer Center · USOsaka Medical Center for Cancer and Cardiovascular Diseases · JPJapanese Red Cross Medical Center · JPNational Cancer Center Hospital East · JPOsaka University · JPShizuoka Cancer Center · JPTochigi Cancer Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe purpose of this phase I study of the dose escalation of oxaliplatin in combination with oral S-1 and pelvic radiation preoperatively for poor-risk lower rectal cancer was to determine the dose-limiting toxicity (DLT) and recommended dose of oxaliplatin.

methodsPatients with cT4 and lateral pelvic lymph node metastasis, and without distant metastasis (cM0), were treated with weekly oxaliplatin, oral S-1 40 mg/m(2) twice daily for 5 days a week, and radiation. A total of 5 weekly doses of oxaliplatin were planned. RT was administered to a total dose of 50.4 Gy in 28 fractions.

resultsWe enrolled 11 patients between December 2009 and January 2012. DLTs were observed at dose level 1 (50 mg/m(2)) in two patients, one of whom experienced grade 3 aspartate aminotransferase elevation and a grade 3 alanine aminotransferase increase, and the other developed grade 4 hypokalemia and a grade 3 alanine aminotransferase increase. Five patients at dose level 2 (60 mg/m(2)) showed no DLTs. The hematological toxicities in all patients were mild and reversible. One patient showed distant metastasis after chemoradiation. Ten of the 11 patients achieved R0 resection by mesorectal resection and lateral lymph node dissection; three of the 10 underwent combined resection of the other organs.

conclusionThis phase I trial of preoperative S-1 in combination with oxaliplatin and radiation for lower rectal cancer with T4 and lateral pelvic lymph node metastasis revealed that the recommended dose of oxaliplatin was 60 mg/m(2) weekly.

Indexed as

Lymph Node ExcisionAdenocarcinomaAdultAgedAlanine TransaminaseAntineoplastic Combined Chemotherapy ProtocolsAspartate AminotransferasesChemoradiotherapy, AdjuvantDiarrheaDose Fractionation, RadiationDrug CombinationsFemaleHumansLymphatic MetastasisMaleMiddle AgedAlanine TransaminaseAspartate AminotransferasesDrug CombinationsOrganoplatinum CompoundsOxaliplatinOxonic AcidS 1 (combination)Tegafur

Identifiers

PMID24839048
OpenAlexW1989553144

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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.