Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer

NCT ID: NCT01434394

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2017-02-28

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.

Conditions

Locally Advanced Malignant Neoplasm; Oral Cancer; Oropharyngeal Carcinoma; Effects of Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neo-adjuvant Erbitux-based chemotherapy

Neo-adjuvant Erbitus-based chemotherapy before surgery: Erbitus, Docetaxel, Cisplatin.

Group Type: EXPERIMENTAL

Neo-adjuvant Erbitux-based chemotherapy

Intervention Type: DRUG

Name/Substance: Erbitux Formulation: 2 mg/ml or 5 mg/ml Dose: 400 mg/m^2 initial, and then 250 mg/m^2 weekly Route: Intravenous infusion Frequency & treatment mode: Weekly Duration: 6 weeks

Name/Substance: Docetaxel Formulation: Liquid (20 mg/2 ml) Dose: 75 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks)

Name/Substance: Cisplatin Formulation: Powder (30 mg) Dose: 75 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks)

Surgery and radiotherapy

Surgery and post-operative radiotherapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Neo-adjuvant Erbitux-based chemotherapy

Name/Substance: Erbitux Formulation: 2 mg/ml or 5 mg/ml Dose: 400 mg/m^2 initial, and then 250 mg/m^2 weekly Route: Intravenous infusion Frequency & treatment mode: Weekly Duration: 6 weeks

Name/Substance: Docetaxel Formulation: Liquid (20 mg/2 ml) Dose: 75 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks)

Name/Substance: Cisplatin Formulation: Powder (30 mg) Dose: 75 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks)

Intervention Type: DRUG

Other Intervention Names

Followed by surgery and radiotherapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

Tongji University

OTHER

Sponsor Role: collaborator

Second Military Medical University

OTHER

Sponsor Role: collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Lai-ping Zhong

Ninth People's Hospital, School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chen-ping Zhang, MD, PhD

Role: STUDY_CHAIR

Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

10DZ1951300

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

9thShanghai

Identifier Type: -

Identifier Source: org_study_id