Through a prospective clinical trial, we intend to combine surgery, induction chemotherapy, target-reduction intensity-modulated radiotherapy and concurrent chemotherapy as an experimental treatment for patients with newly diagnosed resectable nasopharyngeal carcinoma to illuminate whether combined surgery could bring patients better local-regional control and lower adverse reactions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
264
for induction chemotherapy
for induction and concurrent chemotherapy
in active comparator arm
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGFifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGLocal Regional Relapse-Free Survival (LRRFS)
The LRRFS is evaluated and calculated from the date of random assignment until the day of first local regional relapse or until the date of the last follow-up visit.
Time frame: 3 years
Overall Survival (OS)
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
Time frame: 3 years
Progress-free survival (PFS)
Progress-free survival is calculated from the date of randomization to the date of the first progression of any site or death or censored at the date of the last follow-up.
Time frame: 3 years
Distant Metastasis-Free Survival (DMFS)
The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
Time frame: 3 years
Regional Relapse-Free Survival (RRFS)
The RRFS was defined as the duration from the date of random assignment to the date of regional relapse or censored at the date of the last follow-up.
Time frame: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Time frame: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
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in experimental arm
in experimental arm
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\&N35) before treatment, during treatment, after treatment.
Time frame: 3 years
Incidence of treatment related acute complications
The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.
Time frame: 1 years
Incidence of treatment related late complications
The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.
Time frame: 3 years