Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients

Completed

• Conditions: Nasopharyngeal Carcinoma; Malnutrition
• Interventions: Drug: cisplatin and docetaxel

• Registration Number: NCT02575547
• Lead Sponsor: Zhao Chong

Brief Summary

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。

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-09-19
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-14
• Primary Completion: 2020-01
• Study Completion: 2020-06
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NC+CCRT	cisplatin and docetaxel	Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin)

Primary Outcome Measures

Name	Time	Method
Change in Body weight	baseline and 36 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Abnormal Laboratory Values	36 months	To observe patients' complete blood cell count and blood biochemical examination during the treatment and three years after the treatment.
Acute Toxicity	3 months	To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 3.0 when adjuvant chemotherapy and concurrent chemoradiation is used.
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
Adverse Events That Are Related to Treatment	36 months	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.
Tumor regressive rate after treatment	36 months
Late toxicity	36 months	To evaluate the late toxicity with the SOMA criterion after 1/2/3 years of treatment.
Three-year disease free survival rate	36 months

Trial Locations

Locations (1)

Cancer Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China