Head and Neck Cancer
Conditions
Keywords
HNSCC, induction chemotherapy, nimotuzumab
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.
Interventions
DRUGnimotuzumab
nimotuzumab 400 mg d1
DRUGPF regimen (cisplatin and 5-FU)
cisplatin 75 mg/m2 d1 and 5-FU 750 mg/m2/d CIV d1-5
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| pathologic complete response | 8 weeks |
Countries
China
Outcome results
None listed