Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

Fudan University

Status and phase: Completed; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Radiation: Radical radiotherapy; Drug: TPF neoadjuvant chemotherapy; Drug: Concurrent chemotherapy with cisplatin during radiotherapy; Drug: Concurrent nimotuzumab during radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02012062

NPC-IMRT-N

Details and patient eligibility

About

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.

Full description

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

Enrollment: 160 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Arm Cisplatin

Active Comparator group

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

Treatment:

Radiation: Radical radiotherapy

Drug: TPF neoadjuvant chemotherapy

Drug: Concurrent chemotherapy with cisplatin during radiotherapy

Arm Nimotuzumab

Experimental group

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

Treatment:

Radiation: Radical radiotherapy

Drug: TPF neoadjuvant chemotherapy

Drug: Concurrent nimotuzumab during radiotherapy