Clinical trial · Interventional
Xerostomia-optimised IMRT Versus Standard IMRT in NPC
Xerostomia-optimised Intensity-modulated Radiotherapy Versus Standard Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma Patients:a Multicenter Non-inferior 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. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in NPC patients
Conditions
Conditions (1)
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 ,Xerostomia,Radiotherapy | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Optimised neck CTV | Radiation | — | UNRESOLVED |
| standard neck CTV | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study Group
- description
- optimised neck CTV delineation
- interventionNames
- Radiation: Optimised neck CTV
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- standard neck CTV delineation
- interventionNames
- Radiation: standard neck CTV
Primary outcomes (1)
- measure
- Regional recurrence free survival
- timeFrame
- 3 years
- description
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 ≥ 90g/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: * Level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 3cm in level II ; -≥4 nodal regions of ipsilateral neck involvement; * Radiologically suspicious or confirmed involvement in level II area between skull base and the lateral process of C1; * Parotid lymph node and/or parotid gland involvement; * History of parotid disease or surgery; * Previous malignancy or other concomitant malignant disease; * Pregnancy or lactation.
References
Publications (0)
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