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

Nasopharyngeal Cancinoma (NPC)

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