Actively Recruiting
Efficacy and Safety of Hypofractionated Radiotherapy for Nasopharyngeal Carcinoma
Led by The Second Affiliated Hospital of Hainan Medical University · Updated on 2025-01-28
24
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Nasopharyngeal carcinoma (NPC) is a type of head and neck cancer with a significant number of cases occurring in southern China. Radiotherapy is the primary treatment due to the cancer's location and biological behavior. This research evaluates whether hypofractionated radiotherapy, which uses larger doses per session but fewer sessions, is as effective and safe as conventional radiotherapy for NPC patients. The study aims to improve tumor control, reduce treatment duration, and potentially lower side effects and costs. In this study, patients receive hypofractionated radiotherapy with a dose of 2.64 Gy per session, five times a week, totaling 25 sessions and 66 Gy over 5 weeks. This approach shortens treatment time compared to the conventional 7-week schedule and intends to limit tumor cell regrowth during therapy. The trial is a non-inferior, non-randomized controlled design focusing on this specific radiation approach for NPC. Participants will be monitored through various assessments including tumor response at 3, 6, 12, 24, 36, and 60 months, survival rates, and toxicity evaluations at multiple timepoints. Researchers will also measure patient-reported quality of life and treatment tolerance. The involvement includes clinical exams, imaging, lab tests, and follow-up visits over several years to assess both short-term and long-term outcomes and safety.
CONDITIONS
Brief Title
Hypofractionated Radiotherapy for Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- Performance status of 2 or less
- Diagnosed nasopharyngeal non-keratonic carcinoma confirmed by pathology
- At least one evaluable lesion according to Recist1.1 criteria
- Expected survival of at least 6 months
- Normal function of main organs meeting specific blood, biochemical, coagulation, and myocardial enzyme criteria
- Ability and willingness to provide informed consent and comply with study procedures
You will not qualify if you...
- Pregnant or lactating women
- Severe comorbidities preventing tolerance or completion of radiotherapy
- Contraindications to MRI
- Presence of second primary malignancy
- Severe complications such as hypertension, coronary heart disease, mental disease, or prior allergies
- Participation in other research within 4 weeks before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants receive hypofractionated radiotherapy with a dose of 2.64 Gy per session, 5 sessions per week, totaling 25 sessions over 5 weeks.
5 visits per week for a total of 25 visits (in-person)
Duration - Up to 60 months
Participants are monitored for treatment response, toxicities, survival, and quality of life for up to 60 months after treatment completion.
Multiple visits at 1-2 weeks, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, and 60 months post-treatment
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China, 570311
Actively Recruiting
Research Team
Y
yuecan zeng, doctor
J
junnv xu, doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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