Evidence map›Paper›PMID 37537541›Full record

ArticleBMC cancer2023

Involved site radiation therapy in stage I-III nasopharyngeal carcinoma with limited lymph node burden (ISRT-NPC) or elective region irradiation: a study protocol for a multicenter non-inferiority randomized controlled phase III clinical trial.

Yang Liu, Yaqian Han, Feng Liu, Desheng Hu, Zhijian Chen, Peiguo Wang, Jingao Li, Jiyong Qin, Feng Jin, Yexiong Li and 2 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 37% 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.

NCT05145660 phase3active not recruitingnot on this map

Optimization of Cervical Nodal Clinical Tumor Volume for Early and Medium Stage Nasopharyngeal Carcinoma: a Multicenter Non-inferior Randomized Controlled Phase III Clinical Trial

TypeinterventionalSponsorYi JunlinRan2022 to 2027Enrolled414ConditionsNasopharyngeal CarcinomaArmsintensity-modulated radiotherapy (IMRT) with reduced-volume, Chemotherapy
NCT07303023 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

Individualized Versus Standard Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma: A Non-inferiority, Phase III, Multicenter, Prospective, Randomized Controlled Trial

TypeinterventionalSponsorFudan UniversityRan2025 to 2031Enrolled462ConditionsNasopharyngeal Carcinoma (NPC)ArmsIndividualized Neck Irradiation, Standard Neck Irradiation
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

12 authors at 8 institutions in 2 countries.

Yang LiuDepartment of Radiation Oncology, National Clinical Research Center for Cancer/Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli, Chaoyang District, Beijing, 100021, China.
Yaqian HanDepartment of Radiation Oncology, Hubei Cancer Hospital, Wuhan, 430079, Hubei Province, China.
Feng LiuDepartment of Radiation Oncology, Hubei Cancer Hospital, Wuhan, 430079, Hubei Province, China.
Desheng HuDepartment of Radiation Oncology, Hunan Cancer Hospital, Changsha, 410013, Hunan Province, China.
Zhijian ChenDepartment of Radiation Oncology, Guizhou Cancer Hospital, Guiyang, 550000, Guizhou Province, China.
Peiguo WangDepartment of Radiation Oncology, Jiangxi Cancer Hospital, Nanchang, 330029, Jiangxi Province, China.
Jingao LiDepartment of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, China.
Jiyong QinDepartment of Radiation Oncology, Yunnan Cancer Hospital, Kunming, 650100, Yunnan Province, China.
Feng JinDepartment of Radiation Oncology, Cancer hospital Chinese academy of medical science, Shenzhen center, Shenzhen, 518127, Guangzhou Province, China.
Yexiong LiDepartment of Radiation Oncology, National Clinical Research Center for Cancer/Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli, Chaoyang District, Beijing, 100021, China.
Jingbo WangDepartment of Radiation Oncology, National Clinical Research Center for Cancer/Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli, Chaoyang District, Beijing, 100021, China. wangjingbo201001@163.com.
Junlin YiDepartment of Radiation Oncology, National Clinical Research Center for Cancer/Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli, Chaoyang District, Beijing, 100021, China. yijunlin1969@163.com.ORCID http://orcid.org/0000-0002-7083-0216
Chinese Academy of Medical Sciences & Peking Union Medical College · CNHubei Cancer Hospital · CNCancer Hospital of Chinese Academy of Medical Sciences · CNGuizhou Cancer Hospital · CNHunan Cancer Hospital · CNJiangxi Provincial Cancer Hospital · CNSecond People's Hospital of Yunnan Province · CNTianjin Medical University Cancer Institute and Hospital · CN

Funding

Beijing Hope Run Special Fund of Cancer Foundation of China LC2021L06
6 · The paper itself

Abstract

backgroundCurrent radiotherapy guidelines and consensus statements uniformly recommend elective region irradiation (ERI) as the standard strategy for nasopharyngeal carcinoma (NPC). However, given the scarcity of skip-metastasis, the improved assessment accuracy of nodal involvement, and the striking advancements in chemotherapy for NPC, a one-fits-all delineation scheme for clinical target volumes of the nodal region (CTVn) may not be appropriate anymore, and modifications of the CTVn delineation strategy may be warranted. Involved site irradiation (ISI) covering merely the initially involved nodal site and potential extranodal extension has been confirmed to be as effective as ERI with decreased radiation-related toxicities in some malignancies, but has not yet been investigated in NPC. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of ISI with conventional ERI in NPC patients with a limited nodal burden.

methodsISRT-NPC is a prospective, multicenter, open-label, noninferiority, phase III randomized controlled trial. A total of 414 patients will be randomly assigned in a 1:1 ratio to receive ISI or ERI. Randomization will be stratified by institution scale and N stage. Generally, in the ISI group, the high-risk CTV1 (dose: 60 Gy) includes a 1-cm expansion of the positive LN as well as the VIIa and the retrostyloid space above the bilateral transverse process of the atlantoaxial spine (C1), regardless of N status. The low-risk CTV2 (dose: 50 Gy) covers the cervical nodal region with a 3-cm caudal expansion below the transverse process of C1 for N0 disease and a 3-cm expansion below the positive LN for positive LNs. DISCUSSION: The results of this trial are expected to confirm that ISI is a non-inferior strategy to ERI in stage I-III patients with low LN burden, enabling the minimization of treatment-related toxicity and improvement of long-term QoL without compromising regional control.

trial registrationClinicalTrails.gov, NCT05145660. Registered December 6, 2021.

Indexed as

Nasopharyngeal NeoplasmsQuality of LifeClinical Trials, Phase III as TopicEquivalence Trials as TopicHumansLymphatic MetastasisLymph NodesMulticenter Studies as TopicNasopharyngeal CarcinomaProspective StudiesRandomized Controlled Trials as TopicClinical target volumeInvolved site radiation therapyLimited lymph node burdenNasopharyngeal carcinomaQuality of lifeRegional controlToxicity

Identifiers

PMID37537541
PMCPMC10401746
OpenAlexW4385546212

What OpenQuestion holds

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LicenceCC BY
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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.