Elective Level Ib Irradiation in Nasopharyngeal Carcinoma Patients Based on the International Guidelines: an Open-label, Non-inferiority, Multicentre, Randomised Phase 3 Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Fujian Cancer Hospital
- Enrollment
- 398
- Primary Endpoint
- level Ib recurrence rate
Study Overview
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.
Detailed Description
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 extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
level Ib recurrence rate
Time Frame: 3 year
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.
Regional relapse-free survival
Time Frame: 3 year
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.
Secondary Outcomes
- 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)