Actively Recruiting

Age: 18Years - 70Years
All Genders
ID07376603

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

Led by Qiaojuan Guo · Updated on 2026-01-29

169

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of intensity-modulated radiotherapy (IMRT) alone in patients diagnosed with stage IB nasopharyngeal carcinoma (NPC) who do not have high-risk features. This observational study focuses on determining how well this targeted radiation therapy works for this specific group of patients. The study is sponsored by Qiaojuan Guo and aims to provide important information about treatment outcomes for this type of cancer. The study involves 169 patients who will receive definitive IMRT treatment alone. Participants will not receive additional therapies such as chemotherapy or surgery for their primary tumor or metastatic nodes. The radiation is delivered using advanced techniques designed to target the tumor while limiting exposure to surrounding healthy tissues. There are no separate treatment arms; all patients undergo the same radiotherapy approach. During the study, researchers will monitor participants regularly to assess relapse-free survival over three years as the primary outcome. Secondary outcomes include locoregional relapse-free survival, distant metastasis-free survival, overall survival, radiation safety, and quality of life assessments using standard questionnaires at multiple time points up to five years. Safety evaluations occur at inclusion and at 3, 6, 12, 24, 36, and 60 months, allowing thorough monitoring of treatment effects and patient well-being throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histopathologically confirmed, newly diagnosed nasopharyngeal carcinoma
  • Age between 18 and 70 years
  • Stage IB disease (T1-2N1M0) as per the 9th edition AJCC/UICC staging system
  • Upper-neck nodal metastasis only, with all positive nodes at or above the inferior border of the hyoid bone
  • ECOG performance status of 0 to 2
  • Adequate bone marrow function
Not Eligible

You will not qualify if you...

  • Age below 18 years or above 70 years
  • Presence of matted lymph nodes forming a confluent mass
  • Largest metastatic lymph node measuring 3 cm or more in longest dimension
  • Lower-neck nodal metastasis with any positive node below the inferior border of the hyoid bone
  • Prior malignancy except treated basal-cell or squamous-cell skin carcinoma or carcinoma in situ of the cervix
  • Pregnancy or lactation; women of childbearing potential must have a negative pregnancy test and use effective contraception during treatment
  • Previous radiotherapy to the head and neck region
  • Prior chemotherapy or surgery for the primary tumour or metastatic nodes, excluding diagnostic procedures
  • Severe comorbidities such as unstable cardiac disease, renal failure, chronic hepatitis, or uncontrolled psychiatric disorder
  • History of severe hypersensitivity reactions

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 6 to 7 weeks

Participants receive intensity-modulated radiotherapy (IMRT) as the definitive treatment for Stage IB nasopharyngeal carcinoma without high-risk features.

Weekly visits for radiotherapy sessions

Follow-up

Duration - Up to 5 years

Participants are monitored for safety, quality of life, and cancer outcomes after completing radiotherapy.

Visits at inclusion, 3 months, 6 months, 12 months, 24 months, 36 months, and 60 months

Trial Site Locations

Total: 1 location

1

Fujian Cancer Hospital

Fuzhou, Fujian, China, 350000

Actively Recruiting

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Research Team

Q

Qiaojuan Guo, Professor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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