Status:
COMPLETED
Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
Fudan University
Tongji University
Conditions:
Locally Advanced Malignant Neoplasm
Oral Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Epidermal growth factor receptor（EGFR） is a potential target for new anticancer therapy in head and neck squamous cell carcinoma, because blocking the EGFR by a monoclonal antibody results in inhibiti...
Detailed Description
The primary endpoint of this study is the pathological complete response after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy. The second endpoint of this study is the di...
Eligibility Criteria
Inclusion
- Written informed consent prior to any study activities
- Age 18-75
- Histological/cytological and iconography confirmed squamous-celled oral/oropharyngeal cancer
- Stage Ⅲ/Ⅳa (T1-2, N1-2, M0 or T3-4, N0-2, M0, AJCC 2010), operable disease
- Karnofsky performance status (KPS) ≥ 70
- Adequate hematologic function: Neutrophils ≥ 1,500/mm\^3, WBC \> 4,000/mm\^3, Hb \> 10 g/dL, platelet count \> 100,000/mm\^3
- Hepatic function: ALAT/ASAT \< 2.5 times the upper limit of normal (ULN), bilirubin \< 1.5 x ULN
- Renal function: serum creatinine \< 1.5 x ULN
- Life expectancy ≥ 6 months
Exclusion
- Evidence of distant metastatic disease and other oropharyngeal cancers
- Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) before study treatment
- Previous radiotherapy for the primary tumor or lymph nodes
- Previous exposure to epidermal growth factor - targeted therapy
- Prior chemotherapy or immunotherapy for the primary tumor
- Other previous malignancy within 5 years, except adequately treated non-melanoma skin cancer or pre-invasive carcinoma of the cervix
- Any investigational agent prior to the 1st study medication
- Participation in another clinical study within the 30 days prior to Inclusion in this study.
- Peripheral neuropathy \> grade 1
- Known grade 3 or 4 allergic reaction to any of the study treatment
- Creatinine Clearance \< 30 ml/min
- Know drug abuse / alcohol abuse
- Legal incapacity or limited legal capacity
- Active systemic infection
- Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study
- Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol
- Pregnancy (confirmed by serum or urine β-HCG) or lactation period
- Severe cardiac disease such as heart failure, clinically relevant cardiac dysrhythmias, coronary artery disease or myocardial infarction within the last 12 months
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT01440270
Start Date
August 1 2011
End Date
February 1 2017
Last Update
May 5 2020
Active Locations (7)
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1
Eye & Ear Hospital of Fudan University
Shanghai, Shanghai Municipality, China
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
3
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
4
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China