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Elective Level Ib Irradiation in Nasopharyngeal Carcinoma Patients Based on the International Guidelines

NCT05519956 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 398

Last updated 2022-09-19

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

RADIATION

level Ib-covering IMRT

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.

RADIATION

level Ib-sparing IMRT

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.

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Shaojun Lin, DR · Fujian Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-16
Primary Completion
2025-09-01
Completion
2025-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05519956 on ClinicalTrials.gov