A Phase 3 interventional study of Radiation Therapy and Radiation Therapy in Nasopharyngeal Cancinoma (NPC), sponsored by Sun Yat-sen University. Active, not recruiting at 6 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
To evaluate the locoregional control, survival rate, toxicity, and quality of life in patients with nasopharyngeal carcinoma treated with reduced prophylactic irradiation doses to the Low-Risk Clinical Target Volume (CTV).
This phase 3, multicenter, non-inferiority, randomized controlled clinical trial recruits patients with newly diagnosed, untreated, non-distant metastatic, non-keratinizing nasopharyngeal carcinoma (NPC). The intervention involves comparing reduced-dose prophylactic irradiation to standard-dose prophylactic irradiation for the low-risk clinical target volume (CTV). The objective is to compare the locoregional control, survival rate, toxicity, and quality of life between the two groups.
816 studies on the registry are indexed under Nasopharyngeal Carcinoma; 282 are open to participants now.
This study's planned enrollment of 700 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.
Newly diagnosed, untreated, non-distant metastatic, and non-keratinizing NPC; aged between 18 and 70 years; Eastern Cooperative Oncology Group performance score of 0-1; adequate hematologic function (neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥100×109/L, and hemoglobin≥ 90 g/L); adequate renal function (creatinine ≤ 1.5 upper limit of normal [ULN]) or calculated creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); and adequate hepatic function (serum bilirubin ≤ 2.0×ULN, and alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN).
Exclusion Criteria:
Previous chemotherapy treatment, surgery (except diagnostic) or radiotherapy to the neck or nasopharyngeal regions; previous malignancy (except for cured basal cell carcinoma or carcinoma in situ of the cervix); lactation or pregnancy; or severe coexisting illness.
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Radiation: Radiation Therapy
Radiation: Radiation Therapy
PTVnx：70Gy/33Fr；PTVnd：70Gy/33Fr；PTV1：60Gy/33Fr；PTV2：42Gy/26Fr.
PTVnx：70Gy/33Fr；PTVnd：70Gy/33Fr；PTV1：60Gy/33Fr；PTV2：54Gy/33Fr.
Locoregional relapse-free survival
Defined as the time from randomization to either documented local and/or regional relapse or death from any cause (except for metastasis), whichever occurred first.
Time frame: 3 year
Overall survival
Defined as the time from randomization to death from any cause.
Time frame: 3 year
Failure-free survival
Defined as the time from randomisation to disease recurrence (distant metastasis or locoregional recurrence) or death due to any cause, whichever occurred first.
Time frame: 3 year
Distant metastasis-free survival
Defined as the time from randomization to documented distant metastasis or death from any cause (except for locoregional relapse).
Time frame: 3 year
Acute toxicities
Occur within 3 months after RT. Acute radiation-related toxicities are assessed using the National Cancer Institute Common Toxicity Criteria version 5.0 scale.
Time frame: 3 months
Late toxicities
Occur 3 months after RT, graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria
Time frame: 3 year
Patient's quality-of-life
Quality-of-life (QoL) scores were assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaire Core 30 items (QLQ-C30) version 3.0 and the head and neck cancer module (QLQ-H and N35).
Time frame: 1 year
Plan to share: No
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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