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.
histologic confirmation of nonkeratinizing nasopharyngeal carcinoma(WHO II-III);
newly diagnosed stage I to IVa according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system
nasopharyngeal mass confined to one side of nasopharynx and did not exceed the midline(the line between the nasal septum and the midpoint of spinal cord/medulla) detected by electronic nasopharyngoscope (ENS) and magnetic resonance imaging (MRI). Pathological biopsy was recommended if it was unclear whether tumor invaded the contralateral side radiographically.
planned to receive curative IMRT, Chemotherapy drugs should be administered according to Chinese Society of Clinical Oncology (CSCO) guidelines depending on the TNM stage;(T1N0: No chemotherapy required;T2N0：No chemotherapy or concurrent cisplatin chemoradiotherapy if there are adverse prognostic indicators such as Epstein-Barr virus (EBV) DNA>4000 copies，node >3cm or with extranodal extension;T1-2N1: concurrent cisplatin chemoradiotherapy;T3N0: concurrent cisplatin chemoradiotherapy; stage III-Iva: platinum-based neoadjuvant chemotherapy+ concurrent cisplatin chemoradiotherapy+/-metronomic capecitabine therapy )
receipt of treatment with palliative intent;
receipt of previous treatment (radiotherapy, chemotherapy, or surgery [except diagnostic procedures]) to the nasopharynx;
had disease progress after neoadjuvant chemotherapy in local advantage NPC
presence of distant metastasis;
Parallel
Reduction CTVp1
RadiationHigh Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as 5mm margin from GTVp,including pre-induction chemotherapy tumor extension( CTVp1=GTVp+5mm)
Non-reduction CTVp1
RadiationHigh 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
Incidence of hearing impairment worse than graded 2
audiometry and symptoms graded according to the CTCAE (version 5.0).
Overall survival (OS)
the time from randomization to documented death from any cause
Regional Relapse-free Survival(RRFS)
the time from randomization to documented regional recurrence or death from any cause
Distant metastasis-free survival (DMFS)
calculated from randomization to documented distant metastasis or death
Acute toxicities
Occur within 3 months after IMRT according Common Terminology Criteria for Adverse Events Version 5.0
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Zhongshan People's Hospital, Guangdong, China
Lead sponsor
Sun Yat-Sen University Cancer Center
Collaborator
