Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer

Phase 2

Completed

• Conditions: Locally Advanced Malignant Neoplasm; Oral Cancer; Oropharyngeal Carcinoma
• Interventions: Drug: Neo-adjuvant Erbitux-based chemotherapy

• Registration Number: NCT01440270
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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 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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-09-23
• Study First Posted: 2011-09-26
• Primary Completion: 2014-10
• Study Completion: 2017-02
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-02
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neo-adjuvant Erbitux-based chemotherapy	Neo-adjuvant Erbitux-based chemotherapy	Neo-adjuvant Erbitux-based chemotherapy before surgery: Erbitux, Docetaxel, Cisplatin.

Primary Outcome Measures

Name	Time	Method
Pathological Complete Response	Up to 6 months	To evaluate pathological Complete Response (pCR) after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy.

Secondary Outcome Measures

Name	Time	Method
Locoregional Control rates	5 years	Locoregional Control rates (LCR) (1, 3, 5 years)
Disease Free Survival	5 years	Disease Free Survival (DFS) rates (1, 2, 3, 5 years)
Overall Survival	5 years	Overall Survival (OS) rate (3, 5 years)

Trial Locations

Locations (7)

Eye & Ear Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China

Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Shanghai First People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Tongji University Dongfang Hospital; 🇨🇳 Shanghai, Shanghai, China