Back to resultsInduction Chemotherapy With Nimotuzumab in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
nimotuzumab
PF regimen (cisplatin and 5-FU)
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring HNSCC, induction chemotherapy, nimotuzumab
Eligibility Criteria
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
Sites / Locations
- Fudan University Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nimotuzumab
Arm Description
nimotuzumab plus PF regimen
Outcomes
Primary Outcome Measures
overall response rate
Secondary Outcome Measures
pathologic complete response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00910117
Brief Title
Induction Chemotherapy With Nimotuzumab in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Official Title
Phase II Study of Nimotuzumab Plus PF as Induction Chemotherapy in Patients With Locally Advanced HNSCC
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
HNSCC, induction chemotherapy, nimotuzumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nimotuzumab
Arm Type
Experimental
Arm Description
nimotuzumab plus PF regimen
Intervention Type
Drug
Intervention Name(s)
nimotuzumab
Other Intervention Name(s)
h-R3
Intervention Description
nimotuzumab 400 mg d1
Intervention Type
Drug
Intervention Name(s)
PF regimen (cisplatin and 5-FU)
Other Intervention Name(s)
PF
Intervention Description
cisplatin 75 mg/m2 d1 and 5-FU 750 mg/m2/d CIV d1-5
Primary Outcome Measure Information:
Title
overall response rate
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
pathologic complete response
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye Guo, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Induction Chemotherapy With Nimotuzumab in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
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