standard CTV delineation: The anterior border of CTV2 is delineated at the posterior 1/3 of the nasal cavity.
reduced CTV delineation: The anterior border of CTV2 is defined as 5 mm anterior to the posterior nasal cavity anteriorly from the choanae.
Study summary
This is a an open-label, non-inferiority, multicenter, randomized phase III trial aimed to explore the efficacy and safety of shrinking the anterior border of CTV2 in nasopharyngeal carcinoma patients without tumor invasion into the posterior nasal aperture.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. Newly diagnosed, histologically confirmed non-keratinizing carcinoma (WHO classification).
2. Stage I-III disease (AJCC 9th edition).
3. Tumor extends to nasal cavity (including nasal septum).
4. No distant metastasis (M0).
5. Age 18-70 years.
6. Male or non-pregnant female.
7. Scheduled for radiotherapy.
8. ECOG performance status 0-1 .
9. Adequate bone marrow function: white blood cells \>4×10⁹/L, hemoglobin \>90 g/L, platelets \>100×10⁹/L.
10. Normal hepatic/renal function: total bilirubin ≤1.5×ULN, AST/ALT ≤2.5×ULN, alkaline phosphatase ≤2.5×ULN, creatinine clearance ≥60 mL/min.
11. Written informed consent obtained.
Exclusion Criteria:
1. Keratinizing squamous cell carcinoma (WHO Type I) or basaloid squamous cell carcinoma.
2. Age \<18 or \>70 years.
3. Recurrent disease or distant metastasis.
4. No tumor extension into the nasal cavity (including the nasal septum).
5. Prior malignancy (except adequately treated basal/squamous cell skin cancer or cervical carcinoma in situ).
6. Pregnancy/lactation (premenopausal women require pregnancy test; effective contraception mandated).
7. Prior radiotherapy (except non-melanoma skin cancer with lesions outside current portals).
8. Preoperative chemotherapy or surgical resection of primary/neck lesions (excluding diagnostic procedures).
9. Severe coexisting illness.
Primary outcome measure(s)
Local relapse-free survival — 3 year The time from randomization to documented local relapse or death from any cause.
Trial sites (5)
Facility
City
Region
Status
First People's Hospital of Foshan
Foshan
Guangdong
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Affiliated Hospital of Guangdong Medical University
Zhangjiang
Guangdong
The Fourth Affiliated Hospital of Guangxi Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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