IMRT-only treatment for stage IB nasopharyngeal cancer without high-risk features

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study examining outcomes after intensity-modulated radiotherapy (IMRT) given alone to patients with newly diagnosed stage IB (T1-2N1M0) nasopharyngeal carcinoma who lack high-risk nodal features. Eligible patients have only upper-neck nodal involvement (nodes at or above the hyoid), ECOG performance status 0–2, and adequate bone marrow function, while those with matted nodes, nodes ≥3 cm, lower-neck disease, prior malignancy, pregnancy, or outside the 18–70 age range are excluded. The study will track therapeutic effectiveness and safety measures during treatment and follow-up at a single center. Treatment consists of IMRT without planned concurrent chemotherapy.

Why it matters

Who can join: the full rules

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 ≥ 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

Where it's running

• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: Qiaojuan Guo, Professor
• Email: fjzlec@163.com
• Phone: +8615080013157

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.