This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy of standard nutrition treatment versus conventional nutrition treatment in local advanced nasopharyngeal carcinoma patients.
Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III);
All genders，range from 18～65 years old;
Karnofsky performance status(KPS) ≥ 80;
Clinical stage III~IVa(AJCC/UICC 8th);
Have some PEG/PEJ contraindications, such as coagulopathy, recent anticoagulant medications and aspirin, gastric ulcer or history of gastric bleeding, portal hypertension combined with abdominal and esophageal fundal varices, pyloric obstruction due to residual stomach under the costal arch after various major gastrectomy or various reasons;
Distance metastases;
Have or are suffering from other malignant tumors;
Participating in other clinical trials;
Parallel
Standardized nutrition therapy
Other interventionStandardized nutrition therapy with ONS, nasal feeding tube, PEG or parenteral nutrition
Cisplatin
DrugPatients in both arms received concurrent cisplatin chemotherapy:100 mg/m² cisplatin given intravenously every 3 weeks on days 1, 22 concurrently with radiotherapy.
Intensity Modulated Radiation Therapy
RadiationPatients in both arms received Intensity Modulated Radiation Therapy:All target volumes were outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes were defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose was 70-72 Gy to PTVnx (Planning target volume of the primary tumor), 64-70 Gy to PTVnd (Planning target volume of the cervical lymph node),60- 64Gy to PTV1 (Planning target volume 1), and 54-58 Gy to PTV2 (Planning target volume 2) in 30-32 fractions. The details of dose limits for organs at risk were based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).
The incidence of IBW%
To observe the changes and differences in the incidence of the actual weight/ideal weight (IBW%) less than 90% during the treatment of the two groups of patients
The incidence of WL、UBW% and BMI
To observe the changes and differences in the incidence of body weight loss (WL)≥5%/10%, actual body weight/usual body weight (UBW%), body mass index (BMI) before, during and after treatment
Number of Participants With Abnormal Laboratory Values
To observe patients' complete blood cell count and blood biochemical examination during the treatment and three years after the treatment.
Overall survival
From date of recruited to death
Progression free survival
From date of recruited to disease progression
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Sun Yat-sen University
Lead sponsor
Zhongnan Hospital
Collaborator
The First Affiliated Hospital of Xiamen University
Collaborator
Fudan University
Collaborator
Jiangxi Provincial Cancer Hospital
Collaborator
Xijing Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Fujian Cancer Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
Cancer Hospital of Guizhou Province
Collaborator
