Clinical trial NCT05519956: Elective Level Ib Irradiation in Nasopharyngeal Carcinoma Patients Based on the International Guidelines
Official title: Elective Level Ib Irradiation in Nasopharyngeal Carcinoma Patients Based on the International Guidelines: an Open-label, Non-inferiority, Multicentre, Randomised Phase 3 Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2022-08-29
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. newly diagnosed, non-metastatic nasopharyngeal carcinoma histologically confirmed by biopsy;
2. 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;
3. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.

Exclusion Criteria:

1. level Ib involvement with positive pathological results;
2. submandibular glands (SMGs) involvement;
3. involvement of structures that drain to level Ib as the first echelon site (the oral cavity, anterior half of nasal cavity involvement);
4. previous malignancy or other concomitant malignant disease.

Primary outcomes:
measure: Regional relapse-free survival
timeFrame: 3 year
measure: level Ib recurrence rate
timeFrame: 3 year
Secondary outcomes:
measure: Local relapse-free survival
timeFrame: 3 year
measure: Distant metastasis-free survival
timeFrame: 3 year
measure: Overall survival
timeFrame: 3 year
measure: Patient's quality-of-life: dry mouth
timeFrame: 3 year
measure: Patient's quality-of-life: sticky saliva
timeFrame: 3 year
Other outcomes:
Locations:
Study officials:
affiliation: Fujian Cancer Hospital
name: Shaojun Lin, DR
role: STUDY_CHAIR
References: