Actively Recruiting
Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in Nasopharyngeal Carcinoma (PROTECT-NPC): A Multicenter, Non-Inferiority, Open-Label, Randomized Controlled Phase III Clinical Trial
Led by Jiangxi Provincial Cancer Hospital · Updated on 2025-04-10
474
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, open-label, randomized Phase III clinical trial to compare two types of radiotherapy approaches for patients with nasopharyngeal carcinoma. The study focuses on evaluating how well modified delineation radiotherapy protects thyroid function compared to standard delineation radiotherapy. Important outcomes include the incidence of primary hypothyroidism, quality of life, and any adverse events experienced by participants. The trial involves two groups: one receiving modified delineation radiotherapy which adjusts the target area to spare the common carotid artery and reduce thyroid radiation exposure, and the other receiving standard delineation radiotherapy with the usual target boundaries. The modified approach changes the medial and anterior boundaries of the lymphatic drainage areas to potentially lessen thyroid damage. This study spans multiple centers and follows patients during their treatment. Participants will undergo regular follow-ups to monitor regional recurrence-free survival over three years, alongside assessments of overall survival, disease-free survival, and hypothyroidism-free survival. Quality of life will be evaluated at one, two, and three years after treatment. The study includes clinical evaluations, thyroid function tests, and safety monitoring to track outcomes and side effects. Total participant involvement may last several years to capture long-term effects and treatment impact.
CONDITIONS
Brief Title
Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 70 years
- Pathologically confirmed nasopharyngeal carcinoma
- No positive lymph nodes in unilateral or bilateral regions III and IVa
- Clinical stage I-IVa (AJCC/UICC 8th edition) without distant metastasis
- Normal thyroid function
- ECOG performance status of 0-1
- Treatment-nafve patients with no prior antitumor therapy
- No contraindications to radiotherapy or chemotherapy
- Adequate organ function as defined by blood counts and biochemical tests
- Voluntary agreement to participate with informed consent and ability to comply with follow-up
You will not qualify if you...
- History of other malignant tumors (except certain skin cancers or cervical carcinoma in situ)
- Previous radiotherapy excluding outside planned target areas
- History of neck surgery
- Severe comorbidities that pose risks or affect compliance, such as unstable heart disease, kidney disease, chronic hepatitis, uncontrolled diabetes, or psychiatric disorders
- History of hyperthyroidism, hypothyroidism, or immune-related thyroid disorders
- Family or social factors that may risk early study termination, patient safety, or data collection
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.
Duration - According to the radiotherapy schedule
Participants receive radiotherapy with either standard delineation or modified delineation to optimize thyroid function protection.
Duration - Up to 3 years
Participants are monitored for regional recurrence, survival outcomes, thyroid function, and overall health status after treatment.
Visits at 1 year, 2 years, and 3 years post-treatment
Trial Site Locations
Total: 1 location
1
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Actively Recruiting
Research Team
X
Xiaochang Gong, MD
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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