To evaluate the long-term locoregional control, survival rate, late toxicity and quality of life after reducing the target volume in patients with locoregionally advanced nasopharyngeal carcinoma patients treated with induction chemotherapy plus concurrent chemoradiotherapy.
This phase 3, multicenter, non-inferiority, randomized controlled clinical trial recruits patients with newly-diagnosed locoregionally advanced nasopharyngeal carcinoma patients treated with induction chemotherapy plus concurrent chemoradiotherapy. The intervention is delineating the gross tumor volume according to pretreatment tumor extension (the pre-IC GTV group) or post-induction chemotherapy tumor extension (the post-IC GTV group). The objective is to compare the long-term locoregional control, survival rate, late toxicity and quality of life between the two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
445
Delineating the GTV according to the pretreatment or post-IC tumor extension
First People's Hospital of Foshan, Foshan
Foshan, China
People's Hospital of Zhongshan City
Zhongshan, China
Relapse-free survival (RFS)
the time from randomization to documented locoregional recurrence or death from any cause
Time frame: 3 year
Overall survival (OS)
the time from randomization to documented death from any cause
Time frame: 3 year
Late toxicities
Occur 3 months after IMRT, graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria
Time frame: 3 months
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)
Patient-reported QoL
Time frame: 3 year
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)
Patient-reported QoL
Time frame: 3 year
Distant metastasis-free survival (DMFS)
DMFS was calculated from randomization to documented distant metastasis or death.
Time frame: 3 year
Acute toxicities
Occur within 3 months after IMRT
Time frame: 3 months
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