Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

Phase 3

Completed

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: TPF neoadjuvant chemotherapy; Drug: Concurrent nimotuzumab during radiotherapy; Drug: Concurrent chemotherapy with cisplatin during radiotherapy; Radiation: Radical radiotherapy

• Registration Number: NCT02012062
• Lead Sponsor: Fudan University

Brief Summary

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

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

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-16
• Primary Completion: 2016-03
• Study Completion: 2017-08
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm Cisplatin	TPF neoadjuvant chemotherapy	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 Cisplatin	Radical radiotherapy	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	Concurrent nimotuzumab during radiotherapy	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
Arm Cisplatin	Concurrent chemotherapy with cisplatin during radiotherapy	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	TPF neoadjuvant chemotherapy	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
Arm Nimotuzumab	Radical radiotherapy	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

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities)	From Day 1 to Day 90 of radiotherapy

Secondary Outcome Measures

Name	Time	Method
PFS	3 years
OS	3 years

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China