Evidence map›Paper›PMID 31261551›Full record

ArticleMedicine2019

Safety and efficacy of pulsed low-dose rate radiotherapy for local recurrent esophageal squamous cell carcinoma after radiotherapy: Study protocol for a prospective multi-center phase II trial.

Jie Li, Zhenhua Zhao, Guobo Du, Tangzhi Dai, Xuhai Zhen, Hongwei Cai, Dongbiao Liao, Miao Xiang, Yixue Wen, Lidan Geng and 6 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.3field-weighted citation impact, top 20% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. 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

16 authors at 3 institutions in 1 country.

Jie LiDepartment of Head and Neck Oncology, Cancer Center, and State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan.
Zhenhua ZhaoDepartment of Oncology, Mian Yang Central Hospital, Mianyang.
Guobo DuDepartment of Oncology, Affiliated Hospital of North Sichuan Medical College, Nan Chong.
Tangzhi DaiDepartment of Oncology, Mian Yang Central Hospital, Mianyang.
Xuhai ZhenDepartment of Oncology, Mian Yang Central Hospital, Mianyang.
Hongwei CaiDepartment of Oncology, Lang Zhong People's Hospital, Lang Zhong.
Dongbiao LiaoDepartment of Oncology, Mian Yang Central Hospital, Mianyang.
Miao XiangDepartment of Oncology, Mian Yang Central Hospital, Mianyang.
Yixue WenDepartment of Oncology, Mian Yang Central Hospital, Mianyang.
Lidan GengDepartment of Oncology, Mian Yang Central Hospital, Mianyang.
Xiyue YangDepartment of Oncology, Mian Yang Central Hospital, Mianyang.
Gang FengDepartment of Oncology, Mian Yang Central Hospital, Mianyang.
Yu ZhangDepartment of Oncology, Mian Yang Central Hospital, Mianyang.
Jie BaiDepartment of Rehabilitation Medicine, Mian Yang Central Hospital, Mianyang, China.
Lei LiuDepartment of Head and Neck Oncology, Cancer Center, and State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan.
Xiaobo DuDepartment of Oncology, Mian Yang Central Hospital, Mianyang.
Mianyang Central Hospital · CNAffiliated Hospital of North Sichuan Medical College · CNSichuan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRe-irradiation after radiotherapy is a common treatment for locally recurrent esophageal cancer. However, the side effects of re-irradiation are serious. The most serious adverse reactions of re-irradiation include esophageal perforation and hemorrhage caused by esophageal perforation. Studies have shown that pulsed low-dose rate radiotherapy (PLDR) induces a hypersensitivity effect on tumor tissue and a hyper-repair effect on normal tissue, which can simultaneously reduce damage on the normal tissue and increase the therapeutic effect on the tumor. The objective of this study is to explore whether PLDR can reduce rate of esophageal perforation and improve efficacy in patients with recurrent esophageal squamous cell carcinoma (ESCC) after radiotherapy. METHODS AND ANALYSIS: This study is a prospective, multi-center, open, single-arm clinical trial designed to enroll 27 patients with locally recurrent ESCC after radiotherapy with or without chemotherapy. Re-irradiation will be performed using intensity modulated radiation therapy in 50 Gy/25 fractions. The strategy of PLDR includes dividing 2 Gy into 10 fractions, and administering each irradiating dose of 20 cGy at an interval of 3 minutes before the next low-dose irradiation. The actual dose rate of administration each time will be 16.67 cGy /minute. The primary endpoint in this study is the rate of esophageal perforation. The secondary endpoints are the objective remission rate, the palliative effect on quality of life and pain, and the time of disease progression. The observation time is 2 years after the end of the study.

trial registrationClinical trial number: ChiCTR1900020609.

Indexed as

Clinical Trials, Phase II as TopicMulticenter Studies as TopicRe-IrradiationChemoradiotherapyEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaHumansNeoplasm Recurrence, LocalPatient SelectionRadiotherapy DosageRadiotherapy, Intensity-Modulated

Identifiers

PMID31261551
PMCPMC6620741
OpenAlexW2955379118

What OpenQuestion holds

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Registered trials

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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.