Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012062
• Other study ID #: NPC-IMRT-N
• Status: Completed
• Phase: Phase 3
• Start date: July 2012
• Est. completion date: August 2017

Study information

• Verified date: April 2019
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• TPF neoadjuvant chemotherapy

• Concurrent chemotherapy with cisplatin during radiotherapy

• Concurrent nimotuzumab during radiotherapy

Radiation:
• Radical radiotherapy

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Fudan University	Fujian Province Tumor Hospital, The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities)		From Day 1 to Day 90 of radiotherapy
Secondary	PFS		3 years
Secondary	OS		3 years