Evidence map›Paper›PMID 29482649›Full record

Trial reportRadiation oncology (London, England)2018

A randomized phase 3 trial comparing paclitaxel plus 5-fluorouracil versus cisplatin plus 5-fluorouracil in Chemoradiotherapy for locally advanced esophageal carcinoma-the ESO-shanghai 1 trial protocol.

Yun Chen, Zhengfei Zhu, Weixin Zhao, Ling Li, Jinjun Ye, Chaoyang Wu, Huarong Tang, Qin Lin, Jiancheng Li, Yi Xia and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Radiation oncology (London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01591135 (A Phase III Randomized Clinical Trial of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
–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.

NCT01591135 phase3completednot on this map

A Phase III Randomized Clinical Trial of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

TypeinterventionalSponsorFudan UniversityRan2012 to 2018Enrolled436ConditionsEsophageal Squamous Cell CarcinomaArmsPaclitaxel plus 5-fluorouracil, Cisplatin plus 5-fluorouracil, Radiation therapy
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Review
  9. Application of Radiosensitizers in Cancer Radiotherapy.International journal of nanomedicine · 2021
    Review
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

13 authors.

Yun ChenDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, 270 DongAn Road, Shanghai, 200032, China.
Zhengfei ZhuDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, 270 DongAn Road, Shanghai, 200032, China.
Weixin ZhaoDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, 270 DongAn Road, Shanghai, 200032, China.
Ling LiDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, 270 DongAn Road, Shanghai, 200032, China.
Jinjun YeJiangsu Cancer Hospital, Nanjing, China.
Chaoyang WuZhenjiang First People's Hospital, Zhenjiang, China.
Huarong TangZhenjiang First People's Hospital, Zhenjiang, China.
Qin LinThe First Affiliated Hospital of Xiamen University, Xiamen, China.
Jiancheng LiFujian Provincial Cancer Hospital, Fuzhou, China.
Yi XiaFudan University Shanghai Cancer Center Minhang Branch, Shanghai, China.
Yunhai LiFudan University Shanghai Cancer Center Minhang Branch, Shanghai, China.
Jialiang ZhouAffiliated Hospital of Jiangnan University, Wuxi, China.
Kuaile ZhaoDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, 270 DongAn Road, Shanghai, 200032, China. kuaile_z@sina.com.

Funding

National Natural Science Foundation of China Research, China grant 21172043
6 · The paper itself

Abstract

backgroundConcurrent chemoradiotherapy is a standard modality for locally advanced esophageal squamous cell carcinoma (ESCC) patients. Cisplatin combined with 5-fluorouracil continuous infusion (PF) remains the standard concurrent chemotherapy regimen. However, radiotherapy concurrent with PF showed a high incidence of severe side effects. Paclitaxel showed a promising radiosensitivity enhancement in the treatment of esophageal carcinoma in both vitro and vivo studies. The ESO-Shanghai 1 trial examines the hypothesis that paclitaxel plus 5-fluorouracil (TF) concurrent with radiotherapy has better overall survival and lower toxicity for patients with local advanced ESCC.

methodFour hundred thirty-six ESCC patients presenting with stage IIa to IVa will be enrolled in a prospective multicenter randomized phase 3 study. Patients will be randomized to either concurrent chemoradiotherapy with PF (cisplatin 25 mg/m DISCUSSION: The aim of this phase 3 study is to determine whether the TF regimen could replace the standard PF regimen for inoperable ESCC patients. An overall survival benefit of 12% at 3 years should be expected in the TF group to achieve this goal.

trial registrationClinicalTrials.gov Identifier: NCT01591135 . Registered 18 April 2012.

Indexed as

ChemoradiotherapyResearch DesignAdolescentAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCisplatinEsophageal NeoplasmsFemaleFluorouracilFollow-Up StudiesHumansMaleMiddle AgedPaclitaxelCisplatinFluorouracilPaclitaxel5-fluorouracilCisplatinConcurrent chemoradiotherapyEsophageal squamous cell carcinomaPaclitaxel

Identifiers

PMID29482649
PMCPMC5828310

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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.