Elective neck area sparing radiotherapy versus standard radiotherapy in patients with nasopharyngeal carcinoma: an open-label, non-inferiority, multicentre, randomised phase III trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400085114

Enrollment

Unknown

Registered

2024-05-31

Start date

2025-07-14

Completion date

Unknown

Last updated

2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nasopharyngeal carcinoma

Interventions

Test group:Elective neck area sparing radiotherapy

Control group:Standard radiotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients with pathologically confirmed non keratinized or keratinized squamous cell carcinoma; 2.with cT1-4N1-3M0 disease (according to the American Joint Committee on Cancer staging system, 8th edition),excluding cases with only retropharyngeal lymph node metastasis or bilateral lymph node metastasis below the cricoid cartilage; 3.Male or Female, aged between 18 and 70 years; 4.Karnofsky performance status score >= 70; 5.Pre-treatment examination including FDG-PET; 6.No severe heart, lung, liver, kidney and other important organ dysfunction; 7.Normal renal and hepatic function: ALT and AST = 60 mL/min; Adequate bone marrow function: absolute white blood cell count > 4.0 × 10^9/L, neutrophil > 2.0 × 10^9/L, hemoglobin > 90 g/L, platelets > 100 × 10^9/L).

Exclusion criteria

Exclusion criteria: 1.Previous treatment with chemotherapy, radiotherapy, or surgery (except diagnostic) to the nasopharynx or neck; 2.Previous or current malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer and papillary thyroid cancer; 3.Lactation or pregnancy (consider pregnancy test in women of child-bearing age who are sexually active); 4.Other factors that, in the judgment of the investigator, may affect patients’ safety or compliance. For example, serious medical conditions (including psychiatric conditions) requiring treatment, serious laboratory test abnormalities, or other family or social factors.

Design outcomes

Primary

Measure	Time frame
Regional recurrence free survival, RRFS;	—

Secondary

Measure	Time frame
Progression-Free Survival, PFS;Overall Survival, OS;Acute radiation-related toxicity;Late radiation-related toxicity;Quality of life;	—

Countries

China

Contacts

Public ContactCao Caineng

Zhejiang Cancer Hospital

caocn@zjcc.org.cn+86 137 5823 7312

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026