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| Name | Class |
|---|---|
| Wuhan University | OTHER |
| Fudan University | OTHER |
| Fujian Cancer Hospital | OTHER_GOV |
| Zhejiang Cancer Hospital |
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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。
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NC+CCRT | Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin and docetaxel | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body weight | baseline and 36 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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III-IVb(Union for International Cancer Control,UICC 7th) NPC patients with histologic diagnosis of World Health Organization(WHO) II
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| Name | Affiliation | Role |
|---|---|---|
| Chong Zhao, M.D | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center, Sun Yat-sen University | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36872457 | Derived | Miao J, Wang L, Ong EHW, Hu C, Lin S, Chen X, Chen Y, Zhong Y, Jin F, Lin Q, Lin S, Hu X, Zhang N, Wang R, Wang C, Guo X, Yit NLF, Shi H, Tan SH, Mai H, Xie C, Chua MLK, Zhao C. Effects of induction chemotherapy on nutrition status in locally advanced nasopharyngeal carcinoma: a multicentre prospective study. J Cachexia Sarcopenia Muscle. 2023 Apr;14(2):815-825. doi: 10.1002/jcsm.13196. Epub 2023 Mar 5. |
| Label | URL |
|---|---|
| Home Page of Cancer Center, Sun Yat-sen University | View source |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| D011827 | Radiation |
| D004750 | Enteral Nutrition |
| D010288 | Parenteral Nutrition |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| The First Affiliated Hospital of Xiamen University | OTHER |
| Cancer Hospital of Guizhou Province | OTHER |
| Hainan People's Hospital | OTHER |
| First People's Hospital of Foshan | OTHER |
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|
|
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 |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D043823 |
| Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D055585 | Physical Phenomena |
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |