This study is a multicenter RCT to compare 3-year overall survival(OS) rate, progression free survival(PFS),local progression free survival(LPFS),regional progression free survival(RPFS),distant metastasis free survival(DMFS), and toxicities of endonasal endoscopic surgery versus IMRT.
Local and regional recurrence is a common cause of failure after primary radiotherapy for nasopharyngeal carcinoma. Radiotherapy and surgery are the treatments of choice for recurrent NPC. This study aims to compare 3 year overall survival(OS) rate of surgery versus IMRT.A stratified-block randomized approach will be used to randomly assign patients into two treatment groups after stratification according to N staging (N0 vs non-N0). Patients with rNPC will be recruited and randomized into two groups in 1:1 ratio. The primary outcomes will be 3 year overall survival(OS), the secondary outcome measures will be PFS,LPFS,RPFS,DMFS,and toxicities.Assessment will be performed at baseline and during 3 years post-randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
286
143 patients will undergo endonasal endoscopic surgery
143 patients will undergo radiation therapy.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Fudan University Shanghai cancer center
Shanghai, Shanghai Municipality, China
3 year Overall Survival (OS) rate
The proportion of patients who survived 3 years
Time frame: From date of randomization until the date of death from any cause,through study completion,up to 3 years.
progression free survival(PFS)
the time from randomization to the first recording of disease progression or death from any cause.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first,through study completion,up to 3 years.
Local progression free survival(LPFS)
the time from randomization to local failure or death
Time frame: From randomization to local failure or date of death from any cause,through study completion,up to 3 years.
Regional progression free survival(RPFS)
From randomization to regional failure or death
Time frame: From randomization to regional failure or date of death from any cause, through study completion,up to 3 years.
Distant metastasis free survival(DMFS)
From randomization to distant metastasis or death
Time frame: From randomization to distant metastasis or date of death from any cause, through study completion,up to 3 years.
toxicities
Using CTCAE Version5.0 to evaluate
Time frame: From date of randomization until 3 years after randomization,through study completion,up to 3 years.
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