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Brief Title: A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients
Official Title: A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study Comparing 4 Cycles of Neoadjuvant Chemotherapy Combined With Radiotherapy Versus 3cycles of Neoadjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy for the Treatment of N2-3 Nasopharyngeal Carcinoma
Study ID: NCT04061278
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 of intensity modulated radiotherapy, the local-regional area is under well controlled. However, distant metastasis is still the main cause of failure in treatment of stage N2-3 nasopharyngeal carcinoma.The severe toxicity of synchronous chemotherapy and the dose intensity of single drug is not enough to effectively control existing subclinical lesions. Neoadjuvant chemotherapy with sufficient intensity (four cycles) can possible effectively kill subclinical lesions prior to the initiation of concurrent chemoradiotherapy, thereby reducing distant metastasis of stage N2-3 nasopharyngeal carcinoma. Meanwhile, four cycles of chemotherapy have been shown to be well tolerated in other tumors. In conclusion, 4-cycle neoadjuvant chemotherapy in combination with radiotherapy is expected to further control the distant metastasis rate of N2-3 nasopharyngeal carcinoma and improve the survival rate.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Cancer prevention and treatment center, sun yat-sen university, Guandong, Guangdong, China
The first affiliated hospital, college of medicinle, Zhejiang University, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou, Zhejiang, China
Zhejiang Xiaoshan Hospital, Hangzhou, Zhejiang, China
Jinhua Central Hospital, Jinhua, Zhejiang, China
Lishui City Central Hospital, Lishui, Zhejiang, China
Ningbo Yinzhou People's Hospital, Ningbo, Zhejiang, China
Ningbo No.2 Hospital, Ningbo, Zhejiang, China
People's Hospital of Quzhou, Quzhou, Zhejiang, China
Name: Qichun Wei
Affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Role: STUDY_CHAIR