The Multicenter Randomized Phase 3 Trial of Individualized Elective Neck Irradiation Based on MRI in Patients With Nasopharyngeal Carcinoma

Sun Yat-sen University1 site in 1 country446 target enrollmentJanuary 2016

Overview

Brief Summary

Currently, most protocols of nasopharyngeal carcinoma (NPC) of various research bodies such as the Radiation Therapy Oncology Group require routine elective irradiation to the retropharyngeal area and to levels II-V lymph nodal areas regardless of the status of nodal metastasis. Previous studies had confirmed that the pattern of cervical lymph node (LN) metastasis in NPC followed an orderly manner. Retropharyngeal LNs were the most commonly involved, followed by upper neck levels II, III, or VA nodes, and finally to the lower neck nodes including level IV and VB nodes; and the incidence of LN skip metastasis is rare, ranging from 0.5% to 7.9%. It was rare for NPC patients without neck LN metastases to experience neck failure after elective irradiation to levels II, III and VA. It was also confirmed that with unilateral LN metastases of higher-level LNs usually spread down ipsilateral LNs. Thus, the investigators conduct the non-inferior randomized trial to determine the value of elective neck irradiation in NPC patients with unilateral or bilateral uninvolved neck.

Detailed Description

Currently, most protocols of nasopharyngeal carcinoma (NPC) of various research bodies such as the Radiation Therapy Oncology Group require routine elective irradiation to the retropharyngeal area and to levels II-V lymph nodal areas regardless of the status of nodal metastasis. Previous studies had confirmed that the pattern of cervical lymph node (LN) metastasis in NPC followed an orderly manner. Retropharyngeal LNs were the most commonly involved, followed by upper neck levels II, III, or VA nodes, and finally to the lower neck nodes including level IV and VB nodes; and the incidence of LN skip metastasis is rare, ranging from 0.5% to 7.9%. It was rare for NPC patients without neck LN metastases to experience neck failure after elective irradiation to levels II, III and VA. It was also confirmed that with unilateral LN metastases of higher-level LNs usually spread down ipsilateral LNs. Thus, the investigators conduct the non-inferior randomized trial to determine the value of elective neck irradiation in NPC patients with unilateral or bilateral uninvolved neck.

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

May 2018

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Ling-Long Tang

associated professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Regional relapse-free survival

Time Frame: 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 Outcomes

Overall survival(3 year)
Patient's quality-of-life: fatigue(3 year)
Patient's quality-of-life: open mouth(3 year)
Local relapse-free survival(3 year)
Patient's quality-of-life: pain(3 year)
Patient's quality-of-life: appetite loss(3 year)
Patient's quality-of-life: global health status(3 year)
Patient's quality-of-life: physical functioning(3 year)
Patient's quality-of-life: role functioning(3 year)
Patient's quality-of-life: nausea and vomiting(3 year)
Patient's quality-of-life: insomnia(3 year)
Patient's quality-of-life: swallowing(3 year)
Patient's quality-of-life: sticky saliva(3 year)
Patient's quality-of-life: felt ill(3 year)
Patient's quality-of-life: weight gain(3 year)
Patient's quality-of-life: cognitive functioning(3 year)
Patient's quality-of-life: constipation(3 year)
Patient's quality-of-life: trouble social eating(3 year)
Patient's quality-of-life: less sexuality(3 year)
Patient's quality-of-life: teeth(3 year)
Patient's quality-of-life: pain killers(3 year)
Patient's quality-of-life: financial difficulties(3 year)
Radiation-related toxicity(Within 1 month after radiotherapy for acute toxicity; long term for late toxicity)
Distant metastasis-free survival(3 year)
Patient's quality-of-life: emotional functioning(3 year)
Patient's quality-of-life: social functioning(3 year)
Patient's quality-of-life: dyspnoea(3 year)
Patient's quality-of-life: diarrhoea(3 year)
Patient's quality-of-life: speech problems(3 year)
Patient's quality-of-life: weight loss(3 year)
Patient's quality-of-life: sense problems(3 year)
Patient's quality-of-life: trouble social contact(3 year)
Patient's quality-of-life: dry mouth(3 year)
Patient's quality-of-life: coughing(3 year)
Patient's quality-of-life: nutrition supplement(3 year)
Patient's quality-of-life: feeding tube(3 year)