RecruitingNCT07376603
IMRT Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
Intensity-Modulated Radiotherapy Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
Sponsor
Qiaojuan Guo
Enrollment
169 participants
Start Date
Jan 12, 2026
Study Type
OBSERVATIONAL
Conditions
Summary
This observational study aims to evaluate the efficacy and safety of intensity-modulated radiotherapy (IMRT) alone in patients with stage IB nasopharyngeal carcinoma (NPC) without high-risk features. The primary objective is to determine the therapeutic effectiveness of this approach
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria1
- \. Histopathologically confirmed, newly diagnosed nasopharyngeal carcinoma 3. Age 18-70 years 4. Stage IB disease (T1-2N1M0) per the 9th edition AJCC/UICC staging system 5. Upper-neck nodal metastasis only: inferior border of every positive node at or above the inferior border of the hyoid bone 6. ECOG performance status 0-2 7. Adequate bone-marrow function
Exclusion Criteria10
- Age > 70 years or < 18 years
- Matted lymph nodes: two or more contiguous nodes with loss of intervening fat planes and/or extracapsular extension forming a confluent mass
- Largest metastatic lymph-node ≥ 3 cm in the longest dimension
- Lower-neck nodal metastasis: inferior border of any positive node below the inferior border of the hyoid bone
- Prior malignancy except adequately treated basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
- Pregnancy or lactation (serum pregnancy test required for women of child-bearing potential; effective contraception mandatory during treatment)
- Previous radiotherapy to the head-and-neck region
- Prior chemotherapy or surgery for the primary tumour or metastatic nodes (diagnostic procedures excluded)
- Any severe comorbidity that would confer unacceptable risk or compromise protocol adherence, including but not limited to unstable cardiac disease, renal failure, chronic hepatitis, or uncontrolled psychiatric disorder
- History of severe hypersensitivity reactions
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Interventions
RADIATIONIMRT along
All patients administered with definitive radiotherapy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07376603
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