Individualized Elective Neck Irradiation Based on MRI in NPC Patients
NPC-CTVn
The Multicenter Randomized Phase 3 Trial of Individualized Elective Neck Irradiation Based on MRI in Patients With Nasopharyngeal Carcinoma
1 other identifier
interventional
446
1 country
1
Brief Summary
Currently, most protocols of nasopharyngeal carcinoma (NPC) of various research bodies such as the Radiation Therapy Oncology Group require routine elective irradiation to the retropharyngeal area and to levels II-V lymph nodal areas regardless of the status of nodal metastasis. Previous studies had confirmed that the pattern of cervical lymph node (LN) metastasis in NPC followed an orderly manner. Retropharyngeal LNs were the most commonly involved, followed by upper neck levels II, III, or VA nodes, and finally to the lower neck nodes including level IV and VB nodes; and the incidence of LN skip metastasis is rare, ranging from 0.5% to 7.9%. It was rare for NPC patients without neck LN metastases to experience neck failure after elective irradiation to levels II, III and VA. It was also confirmed that with unilateral LN metastases of higher-level LNs usually spread down ipsilateral LNs. Thus, the investigators conduct the non-inferior randomized trial to determine the value of elective neck irradiation in NPC patients with unilateral or bilateral uninvolved neck.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2015
CompletedFirst Posted
Study publicly available on registry
December 30, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedNovember 5, 2021
November 1, 2021
2.3 years
December 16, 2015
November 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Regional relapse-free survival
The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.
3 year
Secondary Outcomes (37)
Radiation-related toxicity
Within 1 month after radiotherapy for acute toxicity; long term for late toxicity
Overall survival
3 year
Local relapse-free survival
3 year
Distant metastasis-free survival
3 year
Patient's quality-of-life: global health status
3 year
- +32 more secondary outcomes
Study Arms (2)
Elective neck irradiation
EXPERIMENTALWhole neck irradiation is given in the involved neck. Elective neck irradiation of Level II,III and Va lymph node area is given in the uninvolved neck, and Level IV and Vb lymph node area were not irradiated in the uninvolved neck.
Whole neck irradiation
ACTIVE COMPARATORWhole neck irradiation is given regardless of the involved or uninvolved neck.
Interventions
Whole neck irradiation is given in the involved neck. Elective neck irradiation of Level II,III and Va lymph node area is given in the uninvolved neck, and Level IV and Vb lymph node area were not irradiated in the uninvolved neck.
Whole neck irradiation is given regardless of the involved or uninvolved neck.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- First People's Hospital of Foshancollaborator
- Guilin Medical Collegecollaborator
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Related Publications (2)
Huang CL, Zhang N, Jiang W, Xie FY, Pei XQ, Huang SH, Wang XY, Mao YP, Li KP, Liu Q, Li JB, Liang SQ, Qin GJ, Hu WH, Zhou GQ, Ma J, Sun Y, Chen L, Tang LL. Reduced-Volume Irradiation of Uninvolved Neck in Patients With Nasopharyngeal Cancer: Updated Results From an Open-Label, Noninferiority, Multicenter, Randomized Phase III Trial. J Clin Oncol. 2024 Jun 10;42(17):2021-2025. doi: 10.1200/JCO.23.02086. Epub 2024 Mar 20.
PMID: 38507662DERIVEDTang LL, Huang CL, Zhang N, Jiang W, Wu YS, Huang SH, Mao YP, Liu Q, Li JB, Liang SQ, Qin GJ, Hu WH, Sun Y, Xie FY, Chen L, Zhou GQ, Ma J. Elective upper-neck versus whole-neck irradiation of the uninvolved neck in patients with nasopharyngeal carcinoma: an open-label, non-inferiority, multicentre, randomised phase 3 trial. Lancet Oncol. 2022 Apr;23(4):479-490. doi: 10.1016/S1470-2045(22)00058-4. Epub 2022 Feb 28.
PMID: 35240053DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linglong Tang, M.D.,PhD
Sun sat-sen University Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associated professor
Study Record Dates
First Submitted
December 16, 2015
First Posted
December 30, 2015
Study Start
January 1, 2016
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
November 5, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share