An interventional study of Reduction CTVp1 and Non-reduction CTVp1 in Nasopharyngeal Carcinoma and Intensity-Modulated Radiotherapy, sponsored by Zhongshan People's Hospital, Guangdong, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-16.
Sponsored by Zhongshan People's Hospital, Guangdong, China · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
CTVp1=GTVp+5mm
Radiation: Reduction CTVp1
CTVp1=GTVp+5mm+whole nasopharynx
Radiation: Non-reduction CTVp1
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)
Local 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
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
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Zhongshan People's Hospital, Guangdong, China