To evaluate the long-term local control, survival rate, acute and late radiation related toxicities, quality of life after reducing high risk primary tumor clinical target volumes (CTVp1) in non-metastatic nasopharyngeal carcinoma treated with IMRT.
This phase 3, multicenter,randomized controlled clinical trial recruits patients with newly-diagnosed non-metastatic nasopharyngeal carcinoma patients treated with IMRT. The intervention is delineating high risk primary tumor clinical target volumes (CTVp1) as GTV+5mm or GTV+5mm+whole nasopharynx. The objective is to compare the long-term local control, survival rate, acute and late radiation related toxicities between the two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
454
High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as 5mm margin from GTVp,including pre-induction chemotherapy tumor extension( CTVp1=GTVp+5mm)
High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as whole nasopharynx as well as 5mm margin from GTVp( CTVp1=GTVp+5mm+whole nasopharynx)
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
RECRUITINGLocal Relapse-free Survival(LRFS)
the time from randomization to documented local recurrence or death from any cause
Time frame: 3 years
Incidence of hearing impairment worse than graded 2
audiometry and symptoms graded according to the CTCAE (version 5.0).
Time frame: 3 years
Overall survival (OS)
the time from randomization to documented death from any cause
Time frame: 3 years
Regional Relapse-free Survival(RRFS)
the time from randomization to documented regional recurrence or death from any cause
Time frame: 3 years
Distant metastasis-free survival (DMFS)
calculated from randomization to documented distant metastasis or death
Time frame: 3 years
Acute toxicities
Occur within 3 months after IMRT according Common Terminology Criteria for Adverse Events Version 5.0
Time frame: 3 months
Late toxicities
3 months after completion of radiotherapy graded according to both the Radiation Therapy Oncology Group criteria and the CTCAE (version 5.0)
Time frame: 3 years
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)
Patient reported quality-of-life data and higher scores indicated more severe symptoms
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Time frame: 3 years
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)
Patient reported quality-of-life data and higher scores indicated more severe symptoms
Time frame: 3 years
radiation-induced otitis media with effusion (OME)
Evaluated by tympanometry
Time frame: 3 years
V60Gy
Volume that received at least 60Gy
Time frame: 3 years