Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer (EAGLE)

Shanghai Jiao Tong University School of Medicine

Status and phase

Completed

Phase 3

Phase 2

Conditions

Locally Advanced Malignant Neoplasm

Effects of Chemotherapy

Oral Cancer

Oropharyngeal Carcinoma

Treatments

Drug: Neo-adjuvant Erbitux-based chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01434394

9thShanghai

10DZ1951300 (Other Grant/Funding Number)

Details and patient eligibility

About

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 inhibition of the stimulation of the receptor, therefore, in inhibition of cell proliferation, enhanced apoptosis, and reduced angiogenesis, invasiveness and metastases. The study hypothesis is that neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy for locally advanced oral/oropharyngeal cancer could benefit the patients on prognosis. The endpoints of this study are the pathological complete response after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy, the survival rate, and the safety.

Full 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 disease free survival rates (1, 2, 3, 5 years), locoregional control rates (1, 3, 5 years), overall survival rate (3, 5 years), and the safety.

Enrollment

243 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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 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
History of severe pulmonary or cardiac disease
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, clinical relevant cardiac dysrhythmias, coronary artery disease or myocardial infarction within the last 12 months