Clinical trial · Interventional
Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma
A Phase II Study of Neoadjuvant Chemotherapy + IMRT Combined With Cetuximab in Advanced T Stage of Nasopharyngeal Carcinoma
NCT01271439CI-TRIAL-00011748REPLACEcompletedPhase 2ClinicalTrials.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 is an open, multicenter phase Ⅱ clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cetuximab (C225) combined with IMRT + neoadjuvant chemotherapy in advanced T stage of nasopharyngeal carcinoma. Besides, to figure out the relationship between patient outcome and EGFR gene copy number, expression and mutation.
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 |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cetuximab
- interventionNames
- Drug: Cetuximab
Primary outcomes (1)
- measure
- 3 Month Complete Response Rate + Partial Response Rate
- timeFrame
- 3 Months
- description
- According to RECIST (Response Evaluation Criteria in Solid Tumors) criteria, Complete response was defined as disappearance of all target lesions, Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions.
Secondary outcomes (10)
- measure
- One-year locoregional control rate
- timeFrame
- 1 year
- description
- locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of nasopharyngeal carcinoma * Range from 18～69 years old * T3-4，N0-2，M0 (AJCC 2009) * KPS ≥ 80 * Nonmetastatic diseases * WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L * ALT or AST \< 1.5×ULN、bilirubin \< 1.5×ULN * 0Serum creatinine \< 1.5×ULN Exclusion Criteria: * Distance metastases * Previously treated (surgery，chemotherapy, radiation therapy，EGFR targeted therapy or immunotherapy) * Second malignancy within 5 years * Precious therapy with an investigational agent * Uncontrolled seizure disorder or other serious neurologic disease * ≥ Grade Ш allergic reaction to any drug including in this study * Clinically significant cardiac or respiratory disease * Creatinine clearance \< 30ml/min * Drug or alcohol addition * Do not have full capacity for civil acts * Severe complication, active infection * Concurrent immunotherapy or hormone therapy for other diseases * Pregnancy or lactation
References
Publications (0)
Data not yet available
No reference posted for this study.