Clinical trial NCT01434394: Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer
Official title: Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Locally Advanced Malignant Neoplasm
Oral Cancer
Oropharyngeal Carcinoma
Effects of Chemotherapy
Keywords: Oral cancer
Oropharyngeal cancer
Induction chemotherapy
Targeted chemotherapy
Surgery
Radiotherapy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Fudan University
name: Tongji University
name: Second Military Medical University
First posted: 2011-09-14
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pathological Complete Response
timeFrame: Up to 6 months
Secondary outcomes:
measure: Disease Free Survival
timeFrame: 5 years
measure: Locoregional Control rates
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 years
measure: Number of Participants with Adverse Events
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
name: Chen-ping Zhang, MD, PhD
role: STUDY_CHAIR
References: