Clinical trial · Observational
IMRT Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
Intensity-Modulated Radiotherapy Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
NCT07376603CI-TRIAL-00101986recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intensity-modulated Radiotherapy | — | UNRESOLVED | — |
| Nasopharyngeal Cancinoma (NPC) | Nasopharyngeal Carcinoma | ALIAS | 0.85 |
| Stage IB | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT along | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- IMRT along
- description
- IMRT Alone for 169 Patients with Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
- interventionNames
- Radiation: IMRT along
Primary outcomes (1)
- measure
- Relapse-Free Survival
- timeFrame
- 3-year
- description
- Time from diagnosis to the disease relapse (either locoregional recurrence or distant metastasis) or death from any cause.
Secondary outcomes (6)
- measure
- Locoregional Relapse-Free Survival
- timeFrame
- 3-year
- description
- Time from diagnosis to first documented locoregional recurrence before the last follow-up visit.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.