Evidence map›Paper›PMID 30971301›Full record

ArticleTrials2019

Chemoradiation versus oesophagectomy for locally advanced oesophageal cancer in Chinese patients: study protocol for a randomised controlled trial.

Ruinuo Jia, Weijiao Yin, Shuoguo Li, Ruonan Li, Junqiang Yang, Tanyou Shan, Dan Zhou, Wei Wang, Lixin Wan, Fuyou Zhou and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02972372 (A Randomized, Open-label, Multicenter Trial of the Chemoradiation Versus Standard Esophagectomy for Locally Advanced Resectable Esophageal Squamous Cell Cancer in Chinese Patients), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT02972372 narecruitingnot on this map

A Randomized, Open-label, Multicenter Trial of the Chemoradiation Versus Standard Esophagectomy for Locally Advanced Resectable Esophageal Squamous Cell Cancer in Chinese Patients

TypeinterventionalSponsorThe First Affiliated Hospital of Henan University of Science and TechnologyRan2016 to 2027Enrolled196ConditionsEsophagus CancerArmsCRT, surgery
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Article
  5. [Complete response after neoadjuvant therapy for esophageal cancer : Implications for surgery].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2022
    Review
  6. Review
  7. Article
  8. 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.

Ruinuo JiaThe First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, 24 Jinghua Road, Luoyang, 471003, China.
Weijiao YinThe First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, 24 Jinghua Road, Luoyang, 471003, China.
Shuoguo LiThe First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, 24 Jinghua Road, Luoyang, 471003, China.
Ruonan LiThe First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, 24 Jinghua Road, Luoyang, 471003, China.
Junqiang YangThe First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, 24 Jinghua Road, Luoyang, 471003, China.
Tanyou ShanThe First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, 24 Jinghua Road, Luoyang, 471003, China.
Dan ZhouThe First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, 24 Jinghua Road, Luoyang, 471003, China.
Wei WangThe First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, 24 Jinghua Road, Luoyang, 471003, China.
Lixin WanNanyang Central Hospital, Nanyang, China.
Fuyou ZhouAnyang Tumour Hospital, The Affiliated Hospital of Henan University of Science and Technology, Anyang, China.
Shegan GaoThe First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, 24 Jinghua Road, Luoyang, 471003, China. gsg112258@163.com.

Funding

National Natural Science Foundation of China 81472234
6 · The paper itself

Abstract

backgroundSurgery is the gold standard treatment for local advanced disease, while definitive concurrent chemoradiotherapy (DCRT) is recommended for those who are medically unable to tolerate major surgery or medically fit patients who decline surgery. The primary aim of this trial is to compare the outcomes in Chinese patients with oesophageal squamous cell cancer with locally advanced resectable disease who have received either surgery or DCRT. METHODS/

designOne hundred ninety-six patients with T1bN + M0 or T2-4aN0-2 M0 oesophageal squamous cell cancer will be randomised to the DCRT group or the surgery group. In the DCRT group, patients will be given intensity-modulated radiation therapy (IMRT) with 50 Gy/25 fractions and basic chemotherapy with 5-fluorouracil regimens. In the surgery group, patients will receive neoadjuvant chemoradiotherapy (NCRT) and standard oesophagectomy. Five years of follow-up will be scheduled for patients. The primary endpoints are 2-year/5-year overall survival; the secondary endpoints are 2-year/5-year progression-free survival, treatment-related adverse events and the patients' quality of life. The main evaluation methods include oesophagoscopy, endoscopic ultrasonography and biopsy, oesophageal barium meal, computed tomography, positron emission tomography-computed tomography, blood tests and questionnaires. DISCUSSION: The preponderant oesophageal cancer pathology type is dramatically different in western Caucasian and Asian oesophageal cancer patients: Caucasian patients present with 80% adenocarcinomas, and Asians patients present with 95% squamous cell carcinomas. This phenomenon needs more in-depth studies to elucidate the differences in these populations. Based on the results of this study, we will show whether DCRT will benefit patients more than oesophagectomy. This study will contribute more evidence to the management of oesophageal squamous cell cancer.

trial registrationClinicalTrials.gov, NCT02972372 . Registered on 26 November 2016.

Indexed as

ChemoradiotherapyEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaAdolescentAdultAgedHumansMiddle AgedMulticenter Studies as TopicProspective StudiesRadiotherapy, ConformalRandomized Controlled Trials as TopicYoung AdultDefinitive chemoradiotherapyOesophageal squamous cell carcinomaOesophagectomy

Identifiers

PMID30971301
PMCPMC6458742

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Registered trials

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.