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Trial Title:
Elective Level Ib Irradiation in Nasopharyngeal Carcinoma Patients Based on the International Guidelines
NCT ID:
NCT05519956
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
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.
Arm group label:
level Ib-covering IMRT
Intervention type:
Radiation
Intervention name:
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.
Arm group label:
level Ib-sparing IMRT
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
September 16, 2022
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05519956