Clinical trial · Interventional
Elective Level Ib Irradiation in Nasopharyngeal Carcinoma Patients Based on the International Guidelines
Elective Level Ib Irradiation in Nasopharyngeal Carcinoma Patients Based on the International Guidelines: an Open-label, Non-inferiority, Multicentre, Randomised Phase 3 Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| level Ib-covering IMRT | Radiation | — | UNRESOLVED |
| level Ib-sparing IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- level Ib-covering IMRT
- description
- 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.
- interventionNames
- Radiation: level Ib-covering IMRT
- type
- EXPERIMENTAL
- label
- level Ib-sparing IMRT
- description
- 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
- interventionNames
- Radiation: level Ib-sparing IMRT
Primary outcomes (2)
- measure
- Regional relapse-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available