To Study the Feasibility and Quality of Life of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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This is an randomized, controlled, phase 3 clinical trial. The purpose of this study is to evaluate whether medial group retropharyngeal node （MRLN） sparing could reduce the incidence of radiation-caused dysphagia and improve patients' quality of life without compromising survival rate.

Detailed Description
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In this study, patients with non-keratinizing stage T1-4 N0-3 M0 NPC(UICC/AJCC 8th edition), except for patients with MRLN metastasis, are randomly assigned to receive MRLN sparing or prophylactic irradiation . Patients in MRLN sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr; while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr. Our primary endpoint is local relapse-free survival (LRFS). Secondary end points include overall survival (OS), incidence of out-field recurrence rate, toxic effects, and quality of life (QOL).All efficacy analyses are conducted in the intention-to treat population, and the safety population include only patients who receive their randomly assigned treatment.

Official Title
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Prospective Randomised Controlled Non-inferior Trial Studying the Feasibility and Potential Quality of Life Benefits of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Radiation: medial group retropharyngeal node（MRLN） sparing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients without medial group retropharyngeal node metastasis; Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type); Tumor staged as T1-4N0-3(according to the 8th AJCC edition); No evidence of distant metastasis (M0); Satisfactory performance status: Karnofsky scale (KPS) ≥ 70; Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: Patients with medial group retropharyngeal node metastasis; Aged > 65 or < 18; Treatment with palliative intent; Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer; Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period); With history of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume); Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes; Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRLN sparing group<br>Patients in medial group retropharyngeal node（MRLN） sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr | Radiation: medial group retropharyngeal node（MRLN） sparing<br>* Patients in MRLN sparing group will not routinely receive MRLN irradiation; while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr.<br>|
| No Intervention: MRLN prophylactic irradiation group<br>Patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local replase-free survival rate | Local failure-free survival is calculated from randomization to the first local failure | 3 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute and late toxicity | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 1 year | 
| Incidence of out-field recurrence rate | Number of participants with out-field recurrence | 3 Year | 
| Dysphagia related quality of life | Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-HN35 | 1 year | 
| Overall survival | Overall survival is calculated from randomization to death from any cause | 3 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal Carcinoma, medial group retropharyngeal node