IMRT Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IMRT along.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Cancinoma (NPC), Intensity-modulated Radiotherapy, Stage IB. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intensity-Modulated Radiotherapy Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
Overview
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
Interventions
- Radiation IMRT along
All patients administered with definitive radiotherapy
Primary outcome measures
- Relapse-Free Survival [Time frame: 3-year]
Secondary outcome measures (6)
- Locoregional Relapse-Free Survival [Time frame: 3-year]
- Distant Metastasis-Free Survival [Time frame: 3-year]
- Overall Survival [Time frame: 3-year]
- Safety of Radiation [Time frame: at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months]
- 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 QLQ-HN35 [Time frame: at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months.]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fujian Cancer Hospital — Fuzhou
Identifiers
NCT: NCT07376603 · NPC0013.1