Evidence map›Paper›PMID 30876442›Full record

Trial reportRadiation oncology (London, England)2019

A phase I/II radiation dose escalation trial using simultaneous integrated boost technique with elective nodal irradiation and concurrent chemotherapy for unresectable esophageal Cancer.

Chen Li, Wenjie Ni, Xin Wang, Zongmei Zhou, Wei Deng, Xiao Chang, Dongfu Chen, Qinfu Feng, Jun Liang, Xiaozhen Wang and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Radiation oncology (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02429622 (A Phase Ⅰ/Ⅱ Study of Simultaneous Integrated Boost Radiotherapy and Concurrent Chemotherapy in Patients With Locally Advanced Esophageal Carcinoma), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

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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.

NCT02429622 phase1 / phase2completednot on this map

A Phase Ⅰ/Ⅱ Study of Simultaneous Integrated Boost Radiotherapy and Concurrent Chemotherapy in Patients With Locally Advanced Esophageal Carcinoma

TypeinterventionalSponsorChinese Academy of Medical SciencesRan2015 to 2016Enrolled80ConditionsEsophageal NeoplasmsArmsIMRT simultaneous integrated boost, Paclitaxel, Nedaplatin, Esophagectomy
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  9. Clinical outcomes and prognostic factors of volumetric modulated arc therapy (VMAT) of esophageal cancer.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2024
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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

15 authors.

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, No.17 Panjiayuan Nanli, 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, No.17 Panjiayuan Nanli, Beijing, 100021, 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, No.17 Panjiayuan Nanli, Beijing, 100021, 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, No.17 Panjiayuan Nanli, Beijing, 100021, China.
Wei 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, No.17 Panjiayuan Nanli, 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, No.17 Panjiayuan Nanli, Beijing, 100021, China.
Dongfu ChenDepartment of Radiation Oncology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.17 Panjiayuan Nanli, Beijing, 100021, China.
Qinfu FengDepartment of Radiation Oncology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.17 Panjiayuan Nanli, Beijing, 100021, China.
Jun LiangDepartment of Radiation Oncology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.17 Panjiayuan Nanli, Beijing, 100021, China.
Xiaozhen 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, No.17 Panjiayuan Nanli, Beijing, 100021, 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, No.17 Panjiayuan Nanli, 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, No.17 Panjiayuan Nanli, Beijing, 100021, China.
Nan BiDepartment of Radiation Oncology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.17 Panjiayuan Nanli, Beijing, 100021, China.
Tao ZhangDepartment of Radiation Oncology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.17 Panjiayuan Nanli, Beijing, 100021, China.
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, No.17 Panjiayuan Nanli, Beijing, 100021, China. xiaozefen@sina.com.

Funding

Beijing Hope Run Special Fund of Cancer Foundation of China LC2016L04Capital Health Research and Development Special Fund 2016-2-4021
6 · The paper itself

Abstract

backgroundTo investigate the safety and tolerability of simultaneous integrated boost (SIB) technique concurrent with elective nodal irradiation (ENI) and dual-drug chemotherapy for patients with unresectable esophageal cancer.

methodsIn phase I, the prophylactic PTV received a stable dose of 50.40Gy/1.80Gy/28f while the boost area was planned with 3 consecutive dose levels: the first dose level was 60.76Gy/2.17Gy/28f, and then escalated approximately every 2 Gy. ENI was incorporated in Clinical Target Volume (CTV), and paclitaxel and nedaplatin were given concurrently for at least 5 weeks. In phase II, enrolled patients were treated with Maximum Tolerated Dose (MTD) obtained in phase I and the compliance rate, survival results and toxicities were evaluated.

resultsFrom December 2014 to April 2017, 53 patients were enrolled. In phase I, 2 out of 6 patients developed Dose-Limiting Toxicity (DLT) at dose level 1. Due to excessive treatment-related toxicities, the escalation process was suspended and de-escalated to 59.92Gy /2.14Gy /28 f. Three patients were treated at this dose level, all of whom completed at least 5 weeks of chemotherapy and none of whom reached a DLT, determining the newly added dose level to be the MTD. In phase II, 44 patients were treated with MTD, 31 of them (70.0%) completed at least 5 weeks of chemotherapy. The most common Grade 3 or 4 toxicities in phase II included leukopenia (21%) and esophagitis (15%). With a median follow-up time of 16.9 months, 1-y OS, DFS and local failure-free survival were 76.9, 63.6 and 78.8% respectively.

conclusionThe SIB technique was feasible and safe at the MTD (95% PGTV/PTV 59.92/50.40Gy/28f) concurrent with ENI and dual-drug chemotherapy for patients with unresectable esophageal cancer.

trial registrationclinicaltrials.gov NCT02429622 . Retrospectively registered on April 24, 2015.

Indexed as

ChemoradiotherapyAdultAgedEsophageal NeoplasmsFemaleHumansMaleMiddle AgedPrognosisRadiotherapy DosageRadiotherapy, Intensity-ModulatedRadiotherapy Planning, Computer-AssistedSurvival RateConcurrent ChemoradiotherapyDose-escalationElective nodal irradiationEsophageal squamous cell carcinomaSimultaneous integrated boost

Identifiers

PMID30876442
PMCPMC6420772

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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.