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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

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