Overview

This trial is active, not recruiting.

Conditions locally advanced malignant neoplasm, oral cancer, oropharyngeal carcinoma
Treatment neo-adjuvant erbitux-based chemotherapy
Phase phase 2
Sponsor Shanghai Jiao Tong University School of Medicine
Collaborator Fudan University
Start date July 2011
End date April 2015
Trial size 145 participants
Trial identifier NCT01440270, EMR 622022237

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Neo-adjuvant Erbitux-based chemotherapy before surgery: Erbitux, Docetaxel, Cisplatin.
neo-adjuvant erbitux-based chemotherapy Followed by surgery and radiotherapy
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) Arms: Neo-adjuvant Erbitux-based chemotherapy

Primary Outcomes

Measure
Pathological Complete Response
time frame: Up to 6 months

Secondary Outcomes

Measure
Disease Free Survival
time frame: 5 years
Locoregional Control rates
time frame: 5 years
Overall Survival
time frame: 5 years
Toxicity
time frame: 5 years

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Neo-adjuvant Erbitux-based Chemotherapy Followed by Surgery and Radiotherapy for Locally Advanced Oral/Oropharyngeal Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Shanghai Jiao Tong University School of Medicine.