๐ฌIn plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1\. 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 Criteria:
1. Age \> 70 years or \< 18 years
2. Matted lymph nodes: two or more contiguous nodes with loss of intervening fat planes and/or extracapsular extension forming a confluent mass
3. Largest metastatic lymph-node โฅ 3 cm in the longest dimension
4. Lower-neck nodal metastasis: inferior border of any positive node below the inferior border of the hyoid bone
5. Prior malignancy except adequately treated basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
6. Pregnancy or lactation (serum pregnancy test required for women of child-bearing potential; effective contraception mandatory during treatment)
7. Previous radiotherapy to the head-and-neck region
8. Prior chemotherapy or surgery for the primary tumour or metastatic nodes (diagnostic procedures excluded)
9. 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
10. History of severe hypersensitivity reactions