Elective Level Ib Irradiation in Nasopharyngeal Carcinoma Patients Based on the International Guidelines
1 other identifier
interventional
398
0 countries
N/A
Brief Summary
Currently, nasopharyngeal carcinoma (NPC) patients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II will be recommended to receive level Ib-covering IMRT according to the International Guidelines. Our previous study, which retrospectively analyzed a cohort of 390 patients, indicated that it should be safe and feasible for patients who only had at least one of the above two radiological features. Thus, the investigators conduct this non-inferior phase 3, randomized trial to further determine the feasibility of sparing level Ib in patients who had level II involvement with ECE, and/or had a MAD of greater than 2cm in level II.
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 Sep 2022
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2022
CompletedFirst Posted
Study publicly available on registry
August 29, 2022
CompletedStudy Start
First participant enrolled
September 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedSeptember 19, 2022
August 1, 2022
3 years
August 26, 2022
September 16, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
level Ib recurrence rate
The level Ib recurrent rate will be calculated by the ratio of mumbers of patients relapsed in level Ib and the numbers of cases in the whole group.
3 year
Secondary Outcomes (5)
Local relapse-free survival
3 year
Distant metastasis-free survival
3 year
Overall survival
3 year
Patient's quality-of-life: dry mouth
3 year
Patient's quality-of-life: sticky saliva
3 year
Study Arms (2)
level Ib-covering IMRT
ACTIVE COMPARATORPatients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II.
level Ib-sparing IMRT
EXPERIMENTALPatients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II
Interventions
Patients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II.
Patients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II.
Eligibility Criteria
You may qualify if:
- newly diagnosed, non-metastatic nasopharyngeal carcinoma histologically confirmed by biopsy;
- the following conditions: ① involvement of level II LNs with extracapsular extension(ECE); ② level II LNs involvement with maximum nodal axial diameter (MAD) greater than 2 cm;
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
You may not qualify if:
- level Ib involvement with positive pathological results;
- submandibular glands (SMGs) involvement;
- involvement of structures that drain to level Ib as the first echelon site (the oral cavity, anterior half of nasal cavity involvement);
- previous malignancy or other concomitant malignant disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shaojun Lin, DR
Fujian Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2022
First Posted
August 29, 2022
Study Start
September 16, 2022
Primary Completion
September 1, 2025
Study Completion
September 30, 2025
Last Updated
September 19, 2022
Record last verified: 2022-08