Clinical trial · Interventional
Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC
Phase Ⅲ Study of Neoadjuvant TPF Chemotherapy Followed by Radiotherapy With Concurrent Nimotuzumab or Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).
NCT02012062CI-TRIAL-00038047completedPhase 3ClinicalTrials.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 study is to evaluate whether concurrent nimotuzumab could decrease the severe acute treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally advanced NPC. Three hundreds and twenty patients will be recruited into this study.
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)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent chemotherapy with cisplatin during radiotherapy | Drug | — | UNRESOLVED |
| Concurrent nimotuzumab during radiotherapy | Drug | — | UNRESOLVED |
| Radical radiotherapy | Radiation | — | UNRESOLVED |
| TPF neoadjuvant chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm Cisplatin
- description
- Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT
- interventionNames
- Drug: TPF neoadjuvant chemotherapy
- Drug: Concurrent chemotherapy with cisplatin during radiotherapy
- Radiation: Radical radiotherapy
- type
- EXPERIMENTAL
- label
- Arm Nimotuzumab
- description
- Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT
- interventionNames
- Drug: TPF neoadjuvant chemotherapy
- Drug: Concurrent nimotuzumab during radiotherapy
- Radiation: Radical radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven poorly differentiated or undifferentiated carcinoma of the nasopharynx. * Stage III and IVA/B NPC patients * KPS \>70 * Age between 18-70 * AGC \> 2000, platelets \> 100,000, AST or ALT\<2 x upper normal, serum creatinine\<1.5mg/dl, creatinine clearance \>50ml/min Exclusion Criteria: * Histology other than poorly differentiated or undifferentiated carcinoma, including keratinized squamous cell carcinoma. * Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations. * Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease. * Patients with simultaneous or prior malignancy (not include basal cell carcinoma of skin) * Prior radiation treatment to the head and neck or any prior chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.