Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients

Study Overview
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Brief Summary
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This is an prospective，open-label, none-interventional, observational， multicenter phase II clinical trial. The purpose of this study is to observe the effect of neoadjuvant chemotherapy followed by concurrent chemoradiation therapy(CCRT) on nutritional status in locoregionally advanced nasopharyngeal carcinoma(NPC) patients, analyse the changes of patients' nutrition status during the treatment and the connection between nutrition changes and curative effects, evaluate nutritional risks under the neoadjuvant chemotherapy and CCRT and provide data and basis for further study。

Official Title
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Effect of Neoadjuvant Chemotherapy Followed by Concurrent Chemo-radiotherapy on Nutritional Status in Locoregionally Advanced Nasopharyngeal Carcinoma Patients: Prospective Observational Study

Conditions
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Nasopharyngeal Carcinoma, Malnutrition

Intervention / Treatment
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* Drug: cisplatin and docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II) All genders，range from 18～65 years old Karnofsky performance status(KPS) ≥ 80 Clinical stage III IVb(UICC 7th) Without significant digestive system disease，nutritional and metabolic diseases or endocrine disease Without significant cardiac，respiratory，kidney or liver disease Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy) white blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 10g/L, platelet(PLT) count ≥ 100×109/L alanine aminotransferase (ALT) or aspartate aminotransferase(AST) < 1.5×upper limit of normal(ULN), bilirubin < 1.5×ULN, alanine aminotransferase (CCR) ≥ 30ml/min Inform consent form Exclusion Criteria: Distance metastases Second malignancy within 5 years Drug or alcohol addition Do not have full capacity for civil acts Active systemic infections Chronic consumptions Mental disorder Pregnancy or lactation Concurrent immunotherapy or hormone therapy for other diseases Severe complication, eg, uncontrolled hypertension

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NC+CCRT<br>Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin) | Drug: cisplatin and docetaxel<br>* NC：cisplatin 75 mg/m2 intravenous infusion in day1，docetaxel 75 mg/m2 intravenous infusion in day1，both drugs are given every 3 weeks, two courses. CCRT: intensity modulation radiation therapy(IMRT) and cisplatin (100mg/m2 on day 1) every three weeks for three\three cycles during radiation therapy(RT). Dietary supplement: enteral nutrition and parenteral nutrition<br>* Other names: enteral nutrition and parenteral nutrition;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body weight |  | baseline and 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Toxicity | To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 3.0 when adjuvant chemotherapy and concurrent chemoradiation is used. | 3 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. | 36 months | 
| Adverse Events That Are Related to Treatment | Using European Organization for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ)-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life. Collecting data before treatment, 1 week after each 4/5 cycles of chemotherapy, 3 years after all treatment finished. | 36 months | 
| Tumor regressive rate after treatment |  | 36 months | 
| Late toxicity | To evaluate the late toxicity with the SOMA criterion after 1/2/3 years of treatment. | 36 months | 
| Three-year locoregional relapse free survival rate |  | 36 months | 
| Three-year distance metastasis free survival rate |  | 36 months | 
| Three-year overall survival rate |  | 36 months | 
| Three-year disease free survival rate |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional Status, Locoregionally Advanced Nasopharyngeal Carcinoma