Actively Recruiting
Xerostomia-optimised IMRT Versus Standard IMRT in NPC
Led by Zhongshan People's Hospital, Guangdong, China · Updated on 2024-05-01
524
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Xerostomia-optimised IMRT Versus Standard IMRT in NPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed nasopharyngeal non-keratinizing carcinoma (WHO II/III)
- Any gender, aged 18 to 70 years
- ECOG performance status of 0 or 1
- Clinical stage I to IVa according to AJCC/UICC 8th edition
- No previous radiotherapy, chemotherapy, or anti-tumor treatment including immunotherapy
- No contraindications to chemotherapy or radiotherapy
- Adequate organ function as defined by blood counts and liver and kidney tests
- Signed informed consent form
You will not qualify if you...
- Level II lymph node involvement with extracapsular extension or largest node >3 cm in level II
- Four or more nodal regions involved on the same side of the neck
- Suspicious or confirmed lymph node involvement between skull base and lateral process of C1 in level II
- Involvement of parotid lymph nodes or parotid gland
- History of parotid gland disease or surgery
- Previous or concurrent other malignant diseases
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhongshan City People's Hospital
Zhongshan, Guangdong, China, 528403
Actively Recruiting
Research Team
G
Gui-qiong Xu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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