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

Oral Cancer Clinical Trial

Official title:

Neo-adjuvant Erbitux-based Chemotherapy Followed by Surgery and Radiotherapy for Locally Advanced Oral/Oropharyngeal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440270
• Other study ID #: EMR 622022237
• Status: Completed
• Phase: Phase 2
• Start date: August 2011
• Est. completion date: February 2017

Study information

• Verified date: May 2020
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: February 2017
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Written informed consent prior to any study activities

• Age 18-75

• Histological/cytological and iconography confirmed squamous-celled oral/oropharyngeal cancer

• Stage ?/?a (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 ß-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

Related Conditions & MeSH terms

• Locally Advanced Malignant Neoplasm
• Mouth Neoplasms
• Neoplasms
• Oral Cancer
• Oropharyngeal Carcinoma
• Oropharyngeal Neoplasms

Intervention

Drug:
• 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) Arms: Neo-adjuvant Erbitux-based chemotherapy

Locations

Country	Name	City	State
China	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	Shanghai First People's Hospital	Shanghai	Shanghai
China	Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Tongji University Dongfang Hospital	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	Fudan University, Second Military Medical University, Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological Complete Response	To evaluate pathological Complete Response (pCR) after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy.	Up to 6 months
Secondary	Disease Free Survival	Disease Free Survival (DFS) rates (1, 2, 3, 5 years)	5 years
Secondary	Locoregional Control rates	Locoregional Control rates (LCR) (1, 3, 5 years)	5 years
Secondary	Overall Survival	Overall Survival (OS) rate (3, 5 years)	5 years