An observational study in Nasopharyngeal Carcinoma and Malnutrition, sponsored by Zhao Chong. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-30.
Sponsored by Zhao Chong · Observational
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。
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 186 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Zhao Chong is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
III-IVb(Union for International Cancer Control,UICC 7th) NPC patients with histologic diagnosis of World Health Organization(WHO) II
Exclusion Criteria:
Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin)
Drug: cisplatin and docetaxel
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
Also known as: radiation, enteral nutrition and parenteral nutrition
Change in Body weight
Time frame: baseline and 36 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 36 months
Tumor regressive rate after treatment
Time frame: 36 months
Late toxicity
To evaluate the late toxicity with the SOMA criterion after 1/2/3 years of treatment.
Time frame: 36 months
Three-year locoregional relapse free survival rate
Time frame: 36 months
Three-year distance metastasis free survival rate
Time frame: 36 months
Three-year overall survival rate
Time frame: 36 months
Three-year disease free survival rate
Time frame: 36 months
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Zhao Chong