Status:
UNKNOWN
A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Nasopharyngeal Carcinoma
Neoadjuvant Chemotherapy
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
At the initial diagnosis of locally advanced nasopharyngeal carcinoma, a considerable proportion of patients have developed distant metastasis, forming subclinical lesions. Nowadays, with the advent o...
Eligibility Criteria
Inclusion
- Non-keratinizing nasopharyngeal carcinoma diagnosed by pathology;
- According to the UICC/AJCC eighth edition staging criteria, clinical staging was T1-4N2 -3M0 (stage N2-3 nasopharyngeal carcinoma);
- Patients who have not received disease-related anti-tumor system therapy;
- Age 18\~70 years;
- Perfect liver and kidney function: total bilirubin ≤1.5 times the upper limit of normal value (ULN); AST and ALT≤2.5 ULN; Alkaline phosphatase ≤2.5 ULN; Creatinine clearance rate ≥80 mL/min;
- Complete blood system function: neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL;
- Cartesian score ≥70; or ECOG PS 0 or 1
- Prior to enrollment, the patients must undergo nasopharynx + neck MRI, chest + upper abdomen CT, ECT and other examinations of the whole body bone.
- Sign the informed consent.
Exclusion
- Patients with distant metastases were identified at the time of diagnosis;
- Patients with severe medical complications, severe organ (heart, lung) dysfunction, or neuropsychiatric disorders at the time of diagnosis;
- Previous cases of other malignancies;Complicated with other malignant tumors;Except for cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or carcinoma in situ of any other site;
- Use any other investigational drug or participate in another clinical trial with therapeutic intent within 3 months prior to enrollment;
- A woman who is pregnant or lactating;
- Known active HIV or HBV, HCV infection;
- Known to be allergic to drugs that may be used;
- The researchers did not consider participants to be eligible for this study.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT04061278
Start Date
August 1 2019
End Date
December 31 2022
Last Update
May 12 2020
Active Locations (12)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
2
Cancer prevention and treatment center, sun yat-sen university
Guandong, Guangdong, China, 510060
3
The first affiliated hospital, college of medicinle, Zhejiang University
Hangzhou, Zhejiang, China, 310009
4
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310009