Actively Recruiting
Intensity-Modulated Radiotherapy Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
Led by Qiaojuan Guo · Updated on 2026-01-29
169
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of intensity-modulated radiotherapy (IMRT) alone in patients diagnosed with stage IB nasopharyngeal carcinoma (NPC) who do not have high-risk features. This observational study focuses on determining how well this targeted radiation therapy works for this specific group of patients. The study is sponsored by Qiaojuan Guo and aims to provide important information about treatment outcomes for this type of cancer. The study involves 169 patients who will receive definitive IMRT treatment alone. Participants will not receive additional therapies such as chemotherapy or surgery for their primary tumor or metastatic nodes. The radiation is delivered using advanced techniques designed to target the tumor while limiting exposure to surrounding healthy tissues. There are no separate treatment arms; all patients undergo the same radiotherapy approach. During the study, researchers will monitor participants regularly to assess relapse-free survival over three years as the primary outcome. Secondary outcomes include locoregional relapse-free survival, distant metastasis-free survival, overall survival, radiation safety, and quality of life assessments using standard questionnaires at multiple time points up to five years. Safety evaluations occur at inclusion and at 3, 6, 12, 24, 36, and 60 months, allowing thorough monitoring of treatment effects and patient well-being throughout the study period.
CONDITIONS
Brief Title
IMRT Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed, newly diagnosed nasopharyngeal carcinoma
- Age between 18 and 70 years
- Stage IB disease (T1-2N1M0) as per the 9th edition AJCC/UICC staging system
- Upper-neck nodal metastasis only, with all positive nodes at or above the inferior border of the hyoid bone
- ECOG performance status of 0 to 2
- Adequate bone marrow function
You will not qualify if you...
- Age below 18 years or above 70 years
- Presence of matted lymph nodes forming a confluent mass
- Largest metastatic lymph node measuring 3 cm or more in longest dimension
- Lower-neck nodal metastasis with any positive node below the inferior border of the hyoid bone
- Prior malignancy except treated basal-cell or squamous-cell skin carcinoma or carcinoma in situ of the cervix
- Pregnancy or lactation; women of childbearing potential must have a negative pregnancy test and use effective contraception during treatment
- Previous radiotherapy to the head and neck region
- Prior chemotherapy or surgery for the primary tumour or metastatic nodes, excluding diagnostic procedures
- Severe comorbidities such as unstable cardiac disease, renal failure, chronic hepatitis, or uncontrolled psychiatric disorder
- History of severe hypersensitivity reactions
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 - Approximately 6 to 7 weeks
Participants receive intensity-modulated radiotherapy (IMRT) as the definitive treatment for Stage IB nasopharyngeal carcinoma without high-risk features.
Weekly visits for radiotherapy sessions
Duration - Up to 5 years
Participants are monitored for safety, quality of life, and cancer outcomes after completing radiotherapy.
Visits at inclusion, 3 months, 6 months, 12 months, 24 months, 36 months, and 60 months
Trial Site Locations
Total: 1 location
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350000
Actively Recruiting
Research Team
Q
Qiaojuan Guo, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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