Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

This is a Phase II Randomized Trial to Compare Paclitaxel combined with DDP Plus Concurrent Chemoradiotherapy With DDP Plus Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Sex

All

Minimum age

18 Years

Maximum age

65 Years

Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing carcinoma.
2. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III.
3. Original clinical staged as IVa-IVb（according to the 7th AJCC edition）.
4. Male and no pregnant female
5. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1.
6. WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
7. With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
8. With normal renal function test (Creatinine ≤ 1.5×ULN)
9. Written informed consent.

Exclusion Criteria:

1. Patients have evidence of relapse or distant metastasis Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
2. Receiving radiotherapy or chemotherapy previously
3. The presence of uncontrolled life-threatening illness
4. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
5. Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.

   Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
6. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
7. Concurrent systemic steroid therapy
8. HIV positive
9. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously

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• BACKGROUNDChen WH, Tang LQ, Guo SS, Chen QY, Zhang L, Liu LT, Qian CN, Guo X, Xie D, Zeng MS, Mai HQ. Prognostic Value of Plasma Epstein-Barr Virus DNA for Local and Regionally Advanced Nasopharyngeal Carcinoma Treated With Cisplatin-Based Concurrent Chemoradiotherapy in Intensity-Modulated Radiotherapy Era. Medicine (Baltimore). 2016 Feb;95(5):e2642. doi: 10.1097/MD.0000000000002642. PMID 26844482
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