Xerostomia-optimised IMRT Versus Standard IMRT in NPC
Recruiting now · Not applicable
Conditions studied: Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy
In brief
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
Key facts
- Study ID
- NCT06282497
- Run by
- Zhongshan People's Hospital, Guangdong, China
- People needed
- 524
- Starts
- 2023-10-23
- Expected to finish
- 2029-10-23
- Last updated by the study team
- 2024-05-01
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Zhongshan City People's Hospital — Zhongshan, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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