Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

Study Overview
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Brief Summary
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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.

Detailed Description
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Scheme: Eligible stage III and IVA/B NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio. - Arm Cisplatin: 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 - Arm nimotuzumab: 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

Official Title
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Phase Ⅲ Study of Neoadjuvant TPF Chemotherapy Followed by Radiotherapy With Concurrent Nimotuzumab or Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: TPF neoadjuvant chemotherapy
* Drug: Concurrent chemotherapy with cisplatin during radiotherapy
* Drug: Concurrent nimotuzumab during radiotherapy
* Radiation: Radical radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm Cisplatin<br>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 | Drug: TPF neoadjuvant chemotherapy<br> <br> Drug: Concurrent chemotherapy with cisplatin during radiotherapy<br> <br> Radiation: Radical radiotherapy<br> <br> |
| Experimental: Arm Nimotuzumab<br>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 | Drug: TPF neoadjuvant chemotherapy<br> <br> Drug: Concurrent nimotuzumab during radiotherapy<br> <br> Radiation: Radical radiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities) |  | From Day 1 to Day 90 of radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | 3 years | 
| OS |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal carcinoma, Neoadjuvant chemotherapy, Concurrent chemotherapy, Nimotuzumab