Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Mouth Neoplasms

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Mouth Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Cetuximab

Cisplatin

Antineoplastic Agents, Immunological

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

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

Neo-adjuvant Erbitux-based chemotherapy

Chen-ping Zhang, MD, PhD

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.

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.

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

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

To evaluate pathological Complete Response (pCR) after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy.

Disease Free Survival (DFS) rates (1, 2, 3, 5 years)

Locoregional Control rates (LCR) (1, 3, 5 years)

Fudan University

Tongji University

Second Military Medical University

Shanghai Jiao Tong University School of Medicine

Ninth People's Hospital, School of Medicine

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Lin Shen, MD

Rui-hua Xu, MD, PhD

Ruihua Xu, MD, PhD

Collect the real clinical background of advanced colorectal cancer c of China.

The Primary Objectives of this study is collect the real clinical background of advanced colorectal cancer treatment situation of China. The Secondary Objectives is the mutation of K-ras , targeting therapy , use present situation of cetuximab and liver metastases treatment situation of colorectal cancer patients.

The Real Clinical Background of Advanced Colorectal Cancer Treatment Situation Survey

Chinese Medical Doctor Association

Principal Investigator

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

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)

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.

Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer

All Adverse Events(AEs),including Serious Adverse Events(SAEs), Exposure of All study drugs \& radiation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer	NCT01440270	Locally Advance... Oral Cancer Oropharyngeal C...	Neo-adjuvant Er...	18 Years - 75 Years	Shanghai Jiao Tong University School of Medicine
Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer	NCT01440270	Locally Advance... Oral Cancer Oropharyngeal C...	Neo-adjuvant Er...	18 Years - 75 Years	Shanghai Jiao Tong University School of Medicine
The Real Clinical Background of Advanced Colorectal Cancer Treatment Situation Survey	NCT01549067	Advanced Malign... Colorectal Canc...		-	Chinese Medical Doctor Association
The Real Clinical Background of Advanced Colorectal Cancer Treatment Situation Survey	NCT01549067	Advanced Malign... Colorectal Canc...		-	Chinese Medical Doctor Association
Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer	NCT01434394	Locally Advance... Oral Cancer Oropharyngeal C... Effects of Chem...	Neo-adjuvant Er...	18 Years - 75 Years	Shanghai Jiao Tong University School of Medicine

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