Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
This study is an open-label, multicentered, evaluator-blinded , randomized clinical trial. Patients with early-stage recurrent nasopharyngeal carcinoma were randomized into the control group and the experimental group. Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery, while patients in the experimental group would be treated with adjuvant therapy such as chemotherapy and immunotherapy. A total of 176 subjects are required, with 88 patients in the control group and 88 patients in the experimental group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
176
Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.
Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.
Eye& ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGFujian Medical University Union Hospital
Fuzhou, China
NOT_YET_RECRUITINGThe People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
DFS
Disease free survival
Time frame: From date of randomization until the date of first documented recurrence, metastasis or date of death from any cause, whichever came first, assessed up to 24 months
OS
Overall Survival
Time frame: From randomization to death of any cause,assessed up to 60 months
LRFS
Local recurrence free survival
Time frame: From randomization to local recurrence or death,assessed up to 24 months
DMFS
Distant metastasis free survival
Time frame: From randomization to distant metastasis or death, assessed up to 24 months
1-and 2-year DFS rate
one- and two-year disease free survival
Time frame: end of 1st year, end of 2nd year
1-and 2-year OS rate
one- and two-year overall survival rate
Time frame: end of 1st year, end of 2nd year
Yuting Lai
CONTACT
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Changhai Hospital
Shanghai, China
RECRUITINGShanghai Sixth People's Hospital
Shanghai, China
NOT_YET_RECRUITINGShanghai Zhongshan Hospital
Shanghai, China
NOT_YET_RECRUITINGShenzhen Second People's Hospital
Shenzhen, China
NOT_YET_RECRUITING