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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
266
Standardized nutrition therapy with ONS, nasal feeding tube, PEG or parenteral nutrition
Patients in both arms received concurrent cisplatin chemotherapy:100 mg/m² cisplatin given intravenously every 3 weeks on days 1, 22 concurrently with radiotherapy.
Patients 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).
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGThe 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
Time frame: 2 months
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
Time frame: 36 months
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.
Time frame: 36 months
Overall survival
From date of recruited to death
Time frame: 36 months
Progression free survival
From date of recruited to disease progression
Time frame: 36 months
Locoregional recurrence free survival
From date of recruited to locoregional recurrence
Time frame: 36 months
Distant metastasis free survival
From date of recruited to distant metastasis
Time frame: 36 months
Nutrition screening and evaluation
To observe the changes and differences of nutrition screening and evaluation (NRS2002 and PG-SGA) before, during and after treatment in the two groups
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Time frame: 36 months
Quality of life: EuroQoL 5 dimension
Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)
Time frame: 36 months
Acute toxicities
Evaluating with CTCAE v5.0
Time frame: through study completion, an average of 2 months
Late toxicity
assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria
Time frame: 36 months