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

Phase 3

Not yet recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Radiation: level Ib-covering IMRT; Radiation: level Ib-sparing IMRT

• Registration Number: NCT05519956
• Lead Sponsor: Fujian Cancer Hospital

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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-26
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-29
• Study Start: 2022-09-16
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-19
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 398

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
level Ib-covering IMRT	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.
level Ib-sparing IMRT	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

Primary Outcome Measures

Name	Time	Method
level Ib recurrence rate	3 year	The level Ib recurrent rate will be calculated by the ratio of mumbers of patients relapsed in level Ib and the numbers of cases in the whole group.
Regional relapse-free survival	3 year	The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.

Secondary Outcome Measures

Name	Time	Method
Distant metastasis-free survival	3 year	The distant metastasis-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to documented distant metastasis or death from any cause. Their differences will be compared between treatment arms using the log-rank test.
Overall survival	3 year	The overall survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to death from any cause. Their differences will be compared between treatment arms using the log-rank test.
Patient's quality-of-life: dry mouth	3 year	European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H\&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
Patient's quality-of-life: sticky saliva	3 year	European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H\&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
Local relapse-free survival	3 year	The local relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to documented local relapse or death from any cause. Their differences will be compared between treatment arms using the log-rank test.