Surgery Plus Reduced Target Chemoradiotherapy vs Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma.
NCT Number: NCT06529562
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nasopharyngeal Carcinoma
Interventions: RADIATION: Surgery combined with Target-reduction intensity-modulated radiotherapy|RADIATION: Surgery combined with Dose-reduction intensity-modulated radiotherapy
Sponsor: Ming-Yuan Chen
Collaborators: Fifth Affiliated Hospital, Sun Yat-Sen University|Sun Yat-sen University|Fifth Affiliated Hospital of Guangzhou Medical University|Huazhong University of Science and Technology Union Hospital (Nanshan Hospital)|The First Affiliated Hospital of University of South China|Guangxi Zhuang Autonomous Region People's Hospital|Nanchang City First Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 384
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-11-01
Completion Date: 2032-11-01
Locations: The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, 519000, China

Summary:
The goal of this clinical trial is to compare surgery plus reduced target chemoradiotherapy with surgery plus reduced dose chemoradiotherapy in newly diagnosed operable Nasopharyngeal Carcinoma.The main questions it aims to answer are:whether endoscopic surgery combined with reduced dose chemoradiotherapy vs surgery plus target reduction chemoradiotherapy can bring substantial survival benefits, lower toxicity, and shorter treatment cycle for patients with operable nasopharyngeal carcinoma .

Primary Outcome Measures: Locoregional Recurrence-Free Survival Time (LRRFS), The time interval between randomization and locoregional recurrence, or censored at the date of the last follow-up., 3 years
Secondary Outcome Measures: 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., 3 years|Incidence of Treatment-Related Adverse Events, The proportion of patients with treatment related adverse events according to NCI-CTCAE 5.0 and RTOG criteria., 1 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 censored at the date of the last follow-up., 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 and follow up., 3 years|Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35), 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 and follow up., 3 years|Progression-Free Survival (PFS), The PFS was defined as the duration from the date of random assignment to the date of disease progression or censored at the date of the last follow-up., 3 years