A Phase 3 interventional study of Intensity Modulated Radiation Therapy and Chemotherapy in Nasopharyngeal Carcinoma and Radiotherapy; Complications, sponsored by Sun Yat-sen University. Active, not recruiting at 7 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The purpose of this study is to evaluate the efficacy of reduced neck prophylactic radiotherapy versus conventional neck prophylactic radiotherapy, and compare the radiotherapy-related adverse events and quality of life in two groups.
816 studies on the registry are indexed under Nasopharyngeal Carcinoma; 282 are open to participants now.
This study's planned enrollment of 474 is above the median of 84 across 668 interventional studies indexed under Nasopharyngeal Carcinoma.
Browse Nasopharyngeal Carcinoma studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive the reduced neck prophylactic irradiation, only the level of positive lymph nodes and its next level.
Radiation: Intensity Modulated Radiation Therapy · Drug: Chemotherapy
Patients will receive the conventional neck prophylactic irradiation, as suggested by the international guideline.
Radiation: Intensity Modulated Radiation Therapy · Drug: Chemotherapy
All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node),60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. The details of dose limits for organs at risk are based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).
Also known as: IMRT
Chemotherapy will be arranged by the physician-in-charge according to the NCCN guideline, patient's stage and physical condition.
Regional recurrence-free survival
From the date of randomization to regional recurrence or any death
Time frame: 3 years
Overall survival
From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up
Time frame: 3 years
Local recurrence-free survival
From the date of randomization to local recurrence or any death
Time frame: 3 years
Distant metastasis-free survival
From the date of randomization to distant metastasis or any death
Time frame: 3 years
Progression free survival
From the date of randomization to local or regional recurrence, distant metastasis or any death
Time frame: 3 years
Acute toxicities
Assessed with CTCAE v5.0
Time frame: From the start of treatment until 3 months post treatment
Late toxicities
Assessed with RTOG/EORTC
Time frame: 3 years post treatment
Quality of life score
Assessed with EORTC-Quality of life questionnaire-C30 version 3.0
Time frame: During treatment and 3 years post treatment
Plan to share: No
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University