Evidence map›Paper›PMID 28796729›Full record

Trial reportDiseases of the colon and rectum2017

Postoperative Chemoradiotherapy After Local Resection for High-Risk T1 to T2 Low Rectal Cancer: Results of a Single-Arm, Multi-Institutional, Phase II Clinical Trial.

Takeshi Sasaki, Yoshinori Ito, Masayuki Ohue, Yukihide Kanemitsu, Takaya Kobatake, Masaaki Ito, Yoshihiro Moriya, Norio Saito

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Diseases of the colon and rectum, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 9% 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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 46 citations in OpenAlex.

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  15. Widespread anorectal lymphovascular networks and tissue drainage: analyses from submucosal India ink injection and indocyanine green fluorescence imaging.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2021
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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

8 authors at 4 institutions in 1 country.

Takeshi Sasaki1 Division of Colorectal Surgery, National Cancer Center Hospital East, Chiba, Japan 2 Department of Therapeutic Radiology, National Cancer Center Hospital, Tokyo, Japan 3 Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan 4 Division of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan 5 Department of Gastroenterological Surgery, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.
Yoshinori Ito
Masayuki Ohue
Yukihide Kanemitsu
Takaya Kobatake
Masaaki Ito
Yoshihiro Moriya
Norio Saito
National Cancer Center Hospital East · JPTokyo National Hospital · JPOsaka Medical Center for Cancer and Cardiovascular Diseases · JPShikoku Cancer Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAfter treatment with local excision for TNM stage I low rectal cancer, the risk of local recurrence is not only high for T2 lesions but also for T1 lesions with features of massive invasion to the submucosal layer and/or lymphovascular invasion.

objectiveThe purpose of this study was to determine the efficacy of chemoradiotherapy combined with local excision in the treatment of T1 to T2 low rectal cancer.

designWe conducted a prospective, single-arm, phase II trial. SETTINGS: This was a multicenter study. PATIENTS: From April 2003 to October 2010, 57 patients were treated with local excision after additional external beam irradiation (45 Gy) plus continuous 5-week intravenous injection of 5-fluorouracil (250 mg/m per day) at 10 domestic hospitals. Fifty-three patients had clinical T1N0 lesions, and 4 had T2N0 lesions in the low rectum, located below the peritoneal reflection. MAIN OUTCOMES MEASURES: The primary end point was disease-free survival at 5 years.

resultsThe completion rate for full-dose chemoradiotherapy was 86% (49/57). Serious, nontransient treatment-related complications were not reported. With a median follow-up of 7.3 years after local excision, the 5-year disease-free survival rate was 94% for the 53 patients with T1 lesions and 75% for the 4 patients with T2 lesions. There were 2 local recurrences during the entire observation period. Anal function after local excision and chemoradiation were kept at almost the same levels as observed before treatment. LIMITATIONS: The study was limited by the small number of registered T2 rectal cancers, retrospective evaluations of quality of life, and the exclusion of poorly differentiated adenocarcinoma (a high-risk feature of T1 lesions).

conclusionsThe addition of chemoradiotherapy to local excision of T1 rectal adenocarcinomas with poor prognostic features including deep submucosal invasion and lymphovascular invasion could improve on less favorable historic oncologic outcomes of local excision alone in this high-risk group for lymph node metastasis. See Video Abstract at http://links.lww.com/DCR/A421.

Indexed as

AdenocarcinomaChemoradiotherapy, AdjuvantColectomyRectal NeoplasmsRectumAdultAgedAntimetabolites, AntineoplasticFemaleFluorouracilHumansJapanMaleMiddle AgedNeoplasm InvasivenessNeoplasm MetastasisAntimetabolites, AntineoplasticFluorouracil

Identifiers

PMID28796729
PMCPMC5553237
OpenAlexW2743504512

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.