Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Nimotuzumab

Fluorouracil

Cisplatin

Antineoplastic Agents, Immunological

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

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

TPF neoadjuvant chemotherapy

Concurrent chemotherapy with cisplatin during radiotherapy

Concurrent nimotuzumab during radiotherapy

Radical radiotherapy

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.

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

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).

Fujian Province Tumor Hospital

The First Affiliated Hospital of Xiamen University

Fudan University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC	NCT02012062	Nasopharyngeal ...	TPF neoadjuvant... Concurrent chem... Concurrent nimo... Radical radioth...	18 Years - 70 Years	Fudan University
Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC	NCT02012062	Nasopharyngeal ...	TPF neoadjuvant... Concurrent chem... Concurrent nimo... Radical radioth...	18 Years - 70 Years	Fudan University

Spots Global Cancer Trial Database for concurrent nimotuzumab during radiotherapy