Actively Recruiting
Reduced Dose Radiotherapy vs Standard Dose Radiotherapy for Early Stage Nasopharyngeal Carcinoma
Led by Hai-Qiang Mai,MD,PhD · Updated on 2025-04-22
342
Participants Needed
1
Research Sites
408 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study investigates whether administering reduced dose is non-inferior to standard dose radiotherapy in terms of 3-year locoregional relapse-free survival (LRRFS) rate for stage I nasopharyngeal carcinoma patients who are sensitive to radiotherapy.
CONDITIONS
Official Title
Reduced Dose Radiotherapy vs Standard Dose Radiotherapy for Early Stage Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, any sex
- Newly diagnosed non-keratinizing nasopharyngeal carcinoma, WHO type II or III, clinical stage I
- Complete response and undetectable EBV DNA after 50.88 Gy radiation
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Women of childbearing potential must use contraception during the study
- Hemoglobin level of at least 90 g/L, white blood cell count of at least 4 x 10^9/L, and platelet count of at least 100 x 10^9/L
- Liver function tests (ALT, AST) less than 1.5 times the upper limit of normal, total bilirubin less than 1.5 times upper limit of normal
- Renal function with serum creatinine less than 1.5 times the upper limit of normal or creatinine clearance at least 60 mL/min
- Ability and willingness to sign informed consent and comply with study requirements
You will not qualify if you...
- Keratinizing squamous cell carcinoma (WHO type I)
- Partial response, stable disease, or progressive disease or detectable EBV DNA after 50.88 Gy radiation
- Previous radiotherapy, chemotherapy, or targeted therapy
- Pregnant or breastfeeding women
- History of other malignant tumors except cured basal cell carcinoma or cervical carcinoma in situ
- Severely impaired heart, liver, lung, kidney, or bone marrow function
- Severe or uncontrolled medical conditions or infections
- Participation in other clinical trials or use of investigational drugs
- Unable or unwilling to provide informed consent
- Other contraindications to treatment
- Emotional or mental illness affecting consent or ability to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Centre
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
H
Hai-Qiang Mai, Dr.
CONTACT
Q
Qiu-Yan Chen, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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