Clinical trial · Interventional
Induction Chemotherapy Followed by Concurrent Radiation With Cetuximab or Cisplatin in Locally Advanced Nasopharyngeal Cancer
Phase II Trial of Docetaxel-Cisplatin Neoadjuvant Chemotherapy Followed by Concurrent Radiotherapy With Cetuximab or Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
NCT01614938CI-TRIAL-00007125unknownPhase 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)
The purpose of this study is to compare the efficacy and toxicity of docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin in locally advanced nasopharyngeal carcinoma.
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 (4)
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- cisplatin-radiotherapy (CRT)
- description
- The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent weekly cisplatin and radiotherapy
- interventionNames
- Drug: Docetaxel
- Radiation: Intensity-modulated radiotherapy
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- cetuximab-radiotherapy (ERT)
- description
- The arm receiving docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent cetuximab and radiotherapy
- interventionNames
- Drug: Cetuximab
- Drug: Cisplatin
- Drug: Docetaxel
- Radiation: Intensity-modulated radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3) 2. Stage Ⅲ-ⅣB disease (AJCC/UICC 2009) 3. ECOG performance status of 0-1 4. Life expectancy of more than 6 months 5. Signed written informed consent 6. Adequate organ function including the following: * Absolute neutrophil count (ANC) \>= 1.5 \* 109/l * Platelets count \>= 100 \* 109/l * Hemoglobin \>= 10 g/dl * AST and ALT \<= 2.5 times institutional upper limit of normal (ULN) * Total bilirubin \<= 1.5 times institutional ULN * Creatinine clearance \>= 50 ml/min * Serum creatine \<= 1 times ULN Exclusion Criteria: 1. Evidence of distant metastasis 2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
References
Publications (1)
- DERIVEDXu T, Liu Y, Dou S, Li F, Guan X, Zhu G. Weekly cetuximab concurrent with IMRT aggravated radiation-induced oral mucositis in locally advanced nasopharyngeal carcinoma: Results of a randomized phase II study. Oral Oncol. 2015 Sep;51(9):875-9. doi: 10.1016/j.oraloncology.2015.06.008. Epub 2015 Jul 7. PMID 26163437