Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer

Phase 2

Completed

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

• Registration Number: NCT01434394
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-02
• Study First Submitted QC: 2011-09-13
• Study First Posted: 2011-09-14
• Status Verified: 2014-05
• Primary Completion: 2014-10
• Study Completion: 2017-02
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neo-adjuvant Erbitux-based chemotherapy	Neo-adjuvant Erbitux-based chemotherapy	Neo-adjuvant Erbitus-based chemotherapy before surgery: Erbitus, 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
Overall Survival	5 years	Overall Survival (OS) rate (3, 5 years)
Disease Free Survival	5 years	Disease Free Survival (DFS) rates (1, 2, 3, 5 years)
Locoregional Control rates	5 years	Locoregional Control rates (LCR) (1, 3, 5 years)
Number of Participants with Adverse Events	5 years	All Adverse Events(AEs),including Serious Adverse Events(SAEs), Exposure of All study drugs \& radiation

Trial Locations

Locations (1)

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