Induction Chemotherapy With Nimotuzumab in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: nimotuzumab; Drug: PF regimen (cisplatin and 5-FU)

• Registration Number: NCT00910117
• Lead Sponsor: Fudan University

Brief Summary

The aim of the study is to evaluate the role of nimotuzumab in the neo-adjuvant setting in patients with locally advanced HNSCC. The hypothesis is that the response would be increased with the combination of nimotuzumab and cisplatin and fluorouracil (PF) regimen.

Detailed Description

Induction chemotherapy followed by radiotherapy is the standard treatment for patients with unresectable HNSCC. However, the role of induction chemotherapy remains uncertain for resectable disease. Therefore, we plan to perform a phase II study to evaluate it, focusing on radiographic and pathologic response after induction chemotherapy. Moreover, a new EGFR monoclonal antibody (nimotuzumab) is incorporated with PF regimen. The hypothesis is the addition of nimotuzumab would improve the response without remarkably increase the toxicity.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-05-29
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-16
• Last Update Posted: 2012-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age range 18-70 years old
• ECOG performance status 0-1
• Histologically confirmed and potentially resectable locally advanced (T2-4, N0-3, M0) HNSCC
• Adequate organ function

Exclusion Criteria

• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Pregnant or lactating women
• Serious uncontrolled diseases and intercurrent infection
• Previous serious cardiac disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nimotuzumab	nimotuzumab	nimotuzumab plus PF regimen
nimotuzumab	PF regimen (cisplatin and 5-FU)	nimotuzumab plus PF regimen

Primary Outcome Measures

Name	Time	Method
overall response rate	6 weeks

Secondary Outcome Measures

Name	Time	Method
pathologic complete response	8 weeks

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China