Clinical trial · Observational
Evaluating the Rationality of the International Guideline About Selective Coverage of Level Ib in CTV With NPC
Evaluating the Rationality of the International Guideline's Recommendations Regarding Selective Coverage of Level Ib in Node Clinical Target Volume With Nasopharyngeal Carcinoma : Results From a Real-world Series
NCT04745741CI-TRIAL-00051523unknownClinicalTrials.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 purpose of this study was to evaluate its rationality in real-world data and provide clinical evidence for the refinement of nodal CTV delineation in nasopharyngeal carcinoma(NPC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IB-positive group | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- IB-positive group
- description
- Patients with level IB metastasis and histologically confirmed positive by biopsy.
- interventionNames
- Radiation: IB-positive group
Primary outcomes (2)
- measure
- regional recurrence-free survival (RRFS)
- timeFrame
- 60 months
- description
- The duration of time to regional failure were calculated from the start of treatment to the dates of recurrence.
- measure
- level IB nodal recurrence-free survival
- timeFrame
- 60 months
- description
- The duration of time to level Ib recurrence were calculated from the start of treatment to the date of Ievel Ib recurrence.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. histologically confirmed NPC by biopsy (clearly recorded in the pathology report or medical history) ; 2. no evidence of distant metastasis at initial diagnosis and receiving radical IMRT in our center 3. the following conditions: ① level IB metastasis, ② involvement of the submandibular gland, ③ involvement of structures that drain to level Ib as the first echelon site ( the oral cavity, anterior half of nasal cavity involvement) ④ involvement of level II LNs with extracapsular extension(because the judgment of extracapsular invasion is greatly influenced by subjective factors, this study only include patients who had high grade ENE(G2/G3 as demonstrated in our previous study: Oral Oncol. 2019 Dec;99:104438.)⑤ level II nodal involvement with maximum nodal axial diameter greater than 2 cm. 4. all patients who were treated at Lin Shaojun's attending group from June 2005 to December 2012. 5. presence of complete baseline magnetic resonance imaging data of the nasopharyngeal skull base and neck and treated in our center at initial diagnosis . Exclusion Criteria: 1. disease progression during IMRT; 2. fail to obtain tumor efficacy evaluation information in the medical records of the research center; 3. previous malignancy or other concomitant malignant disease; 4. receiving blind treatment in clinical research.
References
Publications (0)
Data not yet available
No reference posted for this study.