PMID- 34295813
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220425
IS  - 2234-943X (Print)
IS  - 2234-943X (Electronic)
IS  - 2234-943X (Linking)
VI  - 11
DP  - 2021
TI  - The Prognosis and Feasibility of Extensive Clinical Target Volume in 
      Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma: A Phase II 
      Clinical Trial.
PG  - 669575
LID - 10.3389/fonc.2021.669575 [doi]
LID - 669575
AB  - BACKGROUND: This trial aims to explore the feasibility and safety of 
      postoperative radiotherapy covering all regional lymph node areas for locally 
      advanced thoracic esophageal squamous cell carcinoma patients treated with 
      intensity-modulated radiation therapy (IMRT). METHODS: This was a single-center 
      single-arm, phase II clinical trial initiated in 2014. Patients who were treated 
      with radical transthoracic resection and had negative margins within 3 months and 
      histologically confirmed esophageal squamous cell carcinoma (pT3-4 or N+, M0 
      determined by the 7th edition of the AJCC guidelines) were recruited in this 
      trial. Postoperative radiotherapy was performed with a total dose of 40 Gy in 20 
      fractions using IMRT. Clinical target volumes (CTVs) included the tumor bed, 
      anastomosis, bilateral supraclavicular region, mediastinal lymph nodes, left 
      gastric lymph nodes and celiac trunk lymph nodes. The primary endpoint was the 
      2-year local control rate, and the secondary endpoints were overall survival (OS) 
      and adverse events (AEs). RESULTS: A total of 70 eligible patients were recruited 
      from 2014 to 2016. The 2-year local control rate, as the primary endpoint, was 
      67.3%. In addition, the median OS was 57.0 months, with 1-year and 3-year OS 
      rates of 92.8% and 60.9%, respectively. Among the patients, 28/40 (40%) developed 
      locoregional recurrence, with 25.7% involving hematogenous recurrences. All 
      reported AEs occurred during the course of IMRT or within 6 months thereafter. 
      None of them suffered grade 4 hematological or nonhematological AEs. Nearly all 
      patients completed the entire course of postoperative radiotherapy, with a 
      completion rate of 97.1%. CONCLUSION: For an extensive target volume, 40 Gy is 
      feasible and shows acceptable toxicity in patients with locally advanced thoracic 
      esophageal squamous cell carcinoma, although the local recurrence rate is 
      relatively high. Our findings provide a basis for further exploration of 
      high-dose radiation with extensive CTV combined with chemotherapy. CLINICAL TRIAL 
      REGISTRATION: 
      [http://www.clinicaltrials.gov/ct2/results?cond=&term=NCT02384811&cntry=&state=&city=&dist=], 
      identifier [NCT02384811].
CI  - Copyright (c) 2021 Zhang, Ai, Wang, Chen, Liu, Deng, Yang, Nie, Chen, Zhao and 
      Zhao.
FAU - Zhang, Xiaofei
AU  - Zhang X
AD  - Department of Radiotherapy, Fudan University Shanghai Cancer Center, Shanghai, 
      China.
FAU - Ai, Dashan
AU  - Ai D
AD  - Department of Radiotherapy, Fudan University Shanghai Cancer Center, Shanghai, 
      China.
FAU - Wang, Juanqi
AU  - Wang J
AD  - Department of Radiotherapy, Fudan University Shanghai Cancer Center, Shanghai, 
      China.
FAU - Chen, Yun
AU  - Chen Y
AD  - Department of Radiotherapy, Fudan University Shanghai Cancer Center, Shanghai, 
      China.
FAU - Liu, Qi
AU  - Liu Q
AD  - Department of Radiotherapy, Fudan University Shanghai Cancer Center, Shanghai, 
      China.
FAU - Deng, Jiaying
AU  - Deng J
AD  - Department of Radiotherapy, Fudan University Shanghai Cancer Center, Shanghai, 
      China.
FAU - Yang, Huanjun
AU  - Yang H
AD  - Department of Radiotherapy, Fudan University Shanghai Cancer Center, Shanghai, 
      China.
FAU - Nie, Yongzhan
AU  - Nie Y
AD  - State Key Laboratory of Cancer Biology, Xijing Hospital, Fourth Military Medical 
      University, Xi'an, China.
FAU - Chen, Weiwei
AU  - Chen W
AD  - Third People's Hospital, The Sixth Affiliated Hospital of Nantong University, 
      Yancheng Hospital Affiliated Southeast University Medical College, Yancheng, 
      China.
FAU - Zhao, Weixin
AU  - Zhao W
AD  - Department of Radiotherapy, Fudan University Shanghai Cancer Center, Shanghai, 
      China.
FAU - Zhao, Kuaile
AU  - Zhao K
AD  - Department of Radiotherapy, Fudan University Shanghai Cancer Center, Shanghai, 
      China.
LA  - eng
SI  - ClinicalTrials.gov/NCT02384811
PT  - Journal Article
DEP - 20210702
PL  - Switzerland
TA  - Front Oncol
JT  - Frontiers in oncology
JID - 101568867
PMC - PMC8291030
OTO - NOTNLM
OT  - CTV
OT  - IMRT
OT  - esophageal squamous cell carcinoma
OT  - postoperative treatment
OT  - radiotherapy
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2021/07/24 06:00
MHDA- 2021/07/24 06:01
PMCR- 2021/01/01
CRDT- 2021/07/23 06:51
PHST- 2021/02/19 00:00 [received]
PHST- 2021/05/27 00:00 [accepted]
PHST- 2021/07/23 06:51 [entrez]
PHST- 2021/07/24 06:00 [pubmed]
PHST- 2021/07/24 06:01 [medline]
PHST- 2021/01/01 00:00 [pmc-release]
AID - 10.3389/fonc.2021.669575 [doi]
PST - epublish
SO  - Front Oncol. 2021 Jul 2;11:669575. doi: 10.3389/fonc.2021.669575. eCollection 
      2021.