New-mode Clinical Target Volume Delineation of Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
This is a randomized, phase III, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The aim of this study is to evaluate the efficacy and safety of new-mode reduced volume IMRT versus conventional IMRT, and compare the radiotherapy-related adverse events and quality of life in two groups.

Official Title
-----------------
New-mode Clinical Target Volume Delineation and Dosimetric Analysis in Nasopharyngeal Carcinoma Treated With Intensity-Modulated Radiotherapy

Conditions
-----------------
Nasopharyngeal Carcinoma by AJCC V8 Stage

Intervention / Treatment
-----------------
* Radiation: New-mode reduce-volume target IMRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma; No distant metastatic; Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital; Eastern Cooperative Oncology Group (ECOG) score of 0 or 1; Signing informed consent; Follow up regularly and comply with test requirements. Exclusion Criteria: Disease progression during IMRT; Previous malignancy or other concomitant malignant diseases; The evaluation information of tumor efficacy can not be obtained; Receive blind treatment in other clinical research; Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer); Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc; Active systemic infection; No or limited capacity for civil conduct; The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study; Pregnancy or lactation period;
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New-mode reduced CTVp<br>Patients with newly diagnosed, non-metastatic NPC was given New-mode reduce-volume target IMRT. The CTVp was defined as a subclinical disease consisting of 10 mm margin surrounding GTVnx (not including all nasopharyngeal mucosa) | Radiation: New-mode reduce-volume target IMRT<br>* The CTVp was defined as a subclinical disease consisting of 10 mm margin surrounding GTVnx (not including all nasopharyngeal mucosa)<br>|
| No Intervention: Conventional CTVp<br>Patients with newly diagnosed, non-metastatic NPC was given conventional reduce-volume target IMRT. The CTVp was defined as GTVnx + entire nasopharynx mucosa + 10 mm + corresponding anatomical structures. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local failure-free survival (LFFS) | The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause. | 36 months |