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

Intensity-Modulated Radiotherapy Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features

This trial will test whether IMRT alone can control stage IB nasopharyngeal cancer without high-risk features in adults aged 18–70.

Quick facts

• Study type: Observational
• Enrollment: 169 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fujian Cancer Hospital (Government)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT07376603 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–70 with newly diagnosed stage IB (T1-2N1M0) NPC, ECOG 0–2, with only upper‑neck nodal metastasis (nodes at or above the hyoid) and no matted or ≥3 cm nodes are ideal candidates.

Not a fit: Patients with matted lymph nodes, lower‑neck involvement, a largest node ≥3 cm, prior disqualifying malignancy, pregnancy, or outside the 18–70 age range are unlikely to benefit from an IMRT‑only approach.

Why it matters

Potential benefit: If successful, this approach could let selected patients avoid chemotherapy and its side effects while maintaining good tumor control with radiation alone.

How similar studies have performed: Prior work shows IMRT improves local control in early nasopharyngeal cancer and radiotherapy alone can be effective for very early disease, but the safety and sufficiency of IMRT alone specifically for stage IB with upper‑neck nodes remains less well established.

Eligibility criteria

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 this trial is running

Fuzhou, Fujian

• Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Qiaojuan Guo, Professor

Conditions Nasopharyngeal Cancinoma; Intensity-modulated Radiotherapy; Stage IB; Nasopharyngeal Cancinomar; RT along