Clinical trial · Interventional
Endoscopic Surgery vs. Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma.
Endoscopic Surgery Compared With Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma : A Multicenter, Randomized Controlled Clinical Trial.
NCT06533267CI-TRIAL-00079385recruitingN/AClinicalTrials.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)
The goal of this clinical trial is to compare the survival and adverse reactions differences between endoscopic surgery and intensity modulated radiotherapy for patients with newly diagnosed stage Ⅰ nasopharyngeal carcinoma, aiming to verifying the efficacy and safety of endoscopic surgery for stage Ⅰ nasopharyngeal carcinoma.
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 Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic nasopharyngectomy followed close follow-up | Procedure | — | UNRESOLVED |
| Intensity-modulated Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Surgery plus close follow-up
- description
- Surgery: Endoscopic Nasopharyngectomy: Radical resection of the primary lesion using nasal endoscopy.
- interventionNames
- Procedure: Endoscopic nasopharyngectomy followed close follow-up
- type
- ACTIVE_COMPARATOR
- label
- Intensity modulated radiotherapy
- description
- Radiotherapy: Intensity-modulated Radiotherapy: GTVnx: 69.96Gy/33Fr/2.12Gy CTV1: 59.4Gy/33Fr/1.8Gy CTV2: 54.12Gy/33Fr/1.64Gy
- interventionNames
- Radiation: Intensity-modulated Radiotherapy
Primary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Karnofsky score \>70. * Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) or carcinoma in situ confirmed histologically and/or cytologically. * According to the eighth edition of UICC/AJCC staging, the patient was defined as T1N0M0 stage I. * The maximum short diameters of retropharyngeal lymph nodes and cervical lymph nodes were not more than 0.4cm and 0.6cm respectively, or retropharyngeal lymph nodes and cervical lymph nodes were 0.4-0.5cm and 0.6-1.0cm respectively but PET/CT showed negative. * Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol. Exclusion Criteria: * MRI showed that the primary tumor diameter \>1.5cm, or internal carotid artery vascular malformation which would seriously affect the operation. * Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy. * Suffering severe organ dysfunction or physical disorder which could not tolerate operation or radiotherapy. * Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.
References
Publications (0)
Data not yet available
No reference posted for this study.