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| ID | Type | Description | Link |
|---|---|---|---|
| 10DZ1951300 | Other Grant/Funding Number | 10DZ1951300 |
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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Tongji University | OTHER |
| Second Military Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neo-adjuvant Erbitux-based chemotherapy | Experimental | Neo-adjuvant Erbitus-based chemotherapy before surgery: Erbitus, Docetaxel, Cisplatin. |
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| Surgery and radiotherapy | No Intervention | Surgery and post-operative radiotherapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neo-adjuvant Erbitux-based chemotherapy | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response | To evaluate pathological Complete Response (pCR) after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival | Disease Free Survival (DFS) rates (1, 2, 3, 5 years) | 5 years |
| Locoregional Control rates | Locoregional Control rates (LCR) (1, 3, 5 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chen-ping Zhang, MD, PhD | Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200011 | China |
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| 5 years |
| Overall Survival | Overall Survival (OS) rate (3, 5 years) | 5 years |
| Number of Participants with Adverse Events | All Adverse Events(AEs),including Serious Adverse Events(SAEs), Exposure of All study drugs & radiation | 5 years |
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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