Clinical trial · Interventional
Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma
Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma: a Multi-center, Non-inferiority, Open-label, Randomized Controlled Phase III Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Radiotherapy; Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Intensity Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Reduced CTVn2
- description
- Patients will receive the reduced neck prophylactic irradiation, only the level of positive lymph nodes and its next level.
- interventionNames
- Radiation: Intensity Modulated Radiation Therapy
- Drug: Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Conventional CTVn2
- description
- Patients will receive the conventional neck prophylactic irradiation, as suggested by the international guideline.
- interventionNames
- Radiation: Intensity Modulated Radiation Therapy
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Regional recurrence-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III); * All genders, range from 18-70 years old; * ECOG score 0-1; * Clinical stage I-IVa (AJCC/UICC 8th); * Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy); * No contraindications to chemotherapy or radiotherapy; * Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 9g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase \< 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula); * Sign the consent form. Exclusion Criteria: * Neck lymph nodes exist skipping metastasis; * Distant metastases; * Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma; * Have or are suffering from other malignant tumors; * Participating in other clinical trials; * Pregnancy or lactation; * Have uncontrolled cardiovascular disease; * Severe complication, eg, uncontrolled hypertension; * Mental disorder; * Drug or alcohol addition; * Do not have full capacity for civil acts.
References
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