Evidence map›Paper›PMID 31036088›Full record

ArticleBMC cancer2019

A multicenter phase III study comparing Simultaneous Integrated Boost (SIB) radiotherapy concurrent and consolidated with S-1 versus SIB alone in elderly patients with esophageal and esophagogastric cancer - the 3JECROG P-01 study protocol.

Chen Li, Xiaomin Wang, Xin Wang, Chun Han, Ping Wang, Qingsong Pang, Junqiang Chen, Xinchen Sun, Lan Wang, Wencheng Zhang and 10 more

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial ProtocolComparative Study
In one paragraph

Article in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02979691 (A Phase II/III Study Comparing Simultaneous Integrated Boost), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.1field-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.

NCT02979691 phase2 / phase3completednot on this map

A Phase II/III Study Comparing Simultaneous Integrated Boost (SIB) Intensity Modulated Radiation Therapy (IMRT) With S1 Based SIB-IMRT Followed by Adjuvant Chemotherapy With S1 in Elderly Patients With Esophageal or Esophagogastric Cancer (3JECROG-P01)

TypeinterventionalSponsorChinese Academy of Medical SciencesRan2016 to 2020Enrolled350ConditionsEsophagus Cancer, Esophagogastric Junction Cancer, Radiotherapy, ComplicationsArmsSIB-IMRT, S-1
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 17 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 6 institutions in 2 countries.

Chen LiDepartment of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Xiaomin WangDepartment 4th of Radiation Oncology, Anyang Cancer Hospital, Anyang, 455000, China.
Xin WangDepartment of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Chun HanDepartment of Radiation Oncology, the Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, China.
Ping WangDepartment of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital/National Clinical Research Center for Cancer, Tianjin, 300060, China.
Qingsong PangDepartment of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital/National Clinical Research Center for Cancer, Tianjin, 300060, China.
Junqiang ChenDepartment of Radiation Oncology, Fujian Cancer Hospital/Fujian Medical University Cancer Hospital, Fuzhou, 350014, China.
Xinchen SunDepartment of Radiation Oncology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.
Lan WangDepartment of Radiation Oncology, the Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, China.
Wencheng ZhangDepartment of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital/National Clinical Research Center for Cancer, Tianjin, 300060, China.
Yu LinDepartment of Radiation Oncology, Fujian Cancer Hospital/Fujian Medical University Cancer Hospital, Fuzhou, 350014, China.
Xiaolin GeDepartment of Radiation Oncology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.
Zongmei ZhouDepartment of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Wenjie NiDepartment of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Xiao ChangDepartment of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Jun LiangDepartment of Radiation Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen, 518000, China.
Lei DengDepartment of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Wenqing WangDepartment of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Yidian ZhaoDepartment 4th of Radiation Oncology, Anyang Cancer Hospital, Anyang, 455000, China. ayydz101@163.com.
Zefen XiaoDepartment of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. xiaozefen@sina.com.ORCID http://orcid.org/0000-0003-0503-6814
Chinese Academy of Medical Sciences & Peking Union Medical College · CNTianjin Medical University Cancer Institute and Hospital · CNFujian Medical University · CNHebei Medical University · CNJiangsu Province Hospital · CNAnyang Tumor Hospital · CN

Funding

Beijing Hope Run Special Fund of Cancer Foundation of China LC2016L04National Key Projects of Research and Development of China 2016YFC0904600
6 · The paper itself

Abstract

backgroundThe importance of definitive radiotherapy for elderly patients with esophageal and esophagogastric-junction cancer is pronounced. However, little is known in terms of the best way to combine radiotherapy with other treatment options. This study aims to compare the efficiency of SIB radiotherapy alone with SIB radiotherapy concurrent and consolidated with S-1 for elderly patients. Comprehensive geriatric assessment is also incorporated in the procedure of treatment. METHODS/

designThe study is a two arm, open, randomized multicenter Phase III trial with patients over 70 years old with stage IIA-IVB (UICC 2002, IVB only with metastasis to supraclavicular or celiac lymph nodes) squamous cell carcinoma or adenocarcinoma of esophagus or gastroesophageal junction. A total of 300 patients will be randomized using a 1:1 allocation ratio stratified by disease stage and study site. Patients allocated to the SIB arm will receive definitive SIB radiotherapy (95%PTV/PGTV 50.4Gy/59.92Gy/28f) while those randomized to SIB + S-1 arm will receive definitive SIB radiotherapy concurrent and consolidated with S-1. The primary endpoint of the trial is 1-year overall survival. Secondary objectives include progression-free survival, recurrence-free survival (local-regional and distant), disease failure pattern, toxicity profile as well as quality of life. Besides, detailed radiotherapy protocol and quality assurance procedure have been incorporated into this trial. DISCUSSION: The proportion of elderly patients in esophageal cancer is now growing, but there is a lack of evidence in term of treatment standard for this group of patients, which is what we aim to obtain through this prospective phase III study.

trial registrationclinicaltrials.gov NCT02979691 . Registered November 22, 2016.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsEsophageal NeoplasmsRadiotherapy, Intensity-ModulatedStomach NeoplasmsAdenocarcinomaAgedAged, 80 and overCarcinoma, Squamous CellChemoradiotherapyClinical Trials, Phase III as TopicDrug CombinationsEsophagogastric JunctionFemaleFluorouracilHumansMaleDrug CombinationsFluorouracilOxonic AcidS 1 (combination)TegafurComprehensive geriatric assessmentConcurrent chemoradiotherapyConsolidated chemotherapyDefinitive chemoradiotherapyElderlyEsophageal cancerEsophagogastric junction cancerIntensity modulated radiotherapyRandomized controlled trialS-1Simultaneous integrated boost

Identifiers

PMID31036088
PMCPMC6489222
OpenAlexW2943523227

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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.