Status:
UNKNOWN
Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer
Lead Sponsor:
The Second People's Hospital of Sichuan
Collaborating Sponsors:
Biotech Pharmaceutical Co., Ltd.
Conditions:
Oropharyngeal Cancer
Hypopharyngeal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced squam...
Detailed Description
Locoregionally advanced squamous cell carcinoma of the head and neck(LA-SCCHN) poses one of the most complex management challenges. This stage of disease is still potentially curable, but requires com...
Eligibility Criteria
Inclusion
- Informed consent form
- Histologically confirmed locally advanced (stages III and IVb), squamous cell carcinoma of the oropharynx and hypopharynx
- The tumor mass had to be measurable
- Karnofsky performance status ≥70
- Life expectancy estimated than 6 months
- Hematologic: WBC≥4×109 /L , plateletes≥100×109 /L, haemoglobin ≥100 g/L；
- Hepatic: AST/ALT\<1.5 times upper limit of normal (ULN)；serum bilirubin\<1.5 times ULN;
- Renal: Creatinine\<1.5 times ULN；
Exclusion
- Known distant metastases
- Primary tumor and nodes received surgery(except of biopsy)
- Received other anti EGFR monoclonal antibody treatment
- Previous chemotherapy or radiotherapy
- Participation in other interventional clinical trials within 1 month
- Other malignant tumor (except of non-melanoma skin Cancer or carcinoma in situ of cervix)
- History of serious allergic or allergy
- History of Serious lung or heart disease
- Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2018
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01516996
Start Date
March 1 2012
End Date
March 1 2018
Last Update
March 20 2012
Active Locations (13)
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1
Gansu Province Medical Science Institute
Lanzhou, Gansu, China, 730050
2
Guangxi Tumor Hospital
Nanning, Guangxi, China, 530021
3
GuiZhou Cancer Hospital
Guiyang, Guizhou, China, 550004
4
Neimenggu Tumor Hospital
Baotou, Neimenggu, China, 014030