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NCT Number: NCT07376603

IMRT Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features

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

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Cancer Hospital

Fuzhou, Fujian, 350000, China

Location status: Recruiting

Location contact

Qiaojuan Guo, Professor

CONTACT

[email protected]

+8615080013157

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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

Treatment and study plan

IMRT along

Radiation

All patients administered with definitive radiotherapy

Primary outcomes

  1. Relapse-Free Survival

    Time frame: 3-year

    Time from diagnosis to the disease relapse (either locoregional recurrence or distant metastasis) or death from any cause.

Secondary outcomes

  1. Locoregional Relapse-Free Survival

    Time frame: 3-year

    Time from diagnosis to first documented locoregional recurrence before the last follow-up visit.

  2. Distant Metastasis-Free Survival

    Time frame: 3-year

    Time from diagnosis to first documented distant metastasis before the last follow-up visit

  3. Overall Survival

    Time frame: 3-year

    Time from diagnosis to death from any cause or to the last follow-up visit for patients still alive.

  4. Safety of Radiation

    Time frame: at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months

    Acute and late radiation toxicities were graded with the CTCAE criteria

  5. Quality of life (EORTC QLQ C30)

    Time frame: at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months.

    Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ C30), the range is 0-100, higher scores mean a worse outcome.

  6. Quality of life score QLQ-HN35

    Time frame: at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months.

    The quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire QLQ-HN35; the range is 0-100, with higher scores indicating a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiaojuan Guo, Professor

CONTACT

[email protected]

+8615080013157

Sponsors and collaborators

Lead sponsor

Qiaojuan Guo

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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