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Verify the effect and the incidence of oral mucositis of concurrent chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy.
The predictive effect of Apurinic/apyrimidinic endonuclease 1(APE1)/ Ref-1 protein and Apurinic/apyrimidinic endonuclease 1(APE1)/Ref-1 antibody on oral mucositis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RT concurrent with cetuximab | Experimental | Selected 60 patients with locally advanced squamous cell carcinoma of the head and neck. They will be randomized to concurrent chemoradiotherapy versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy.To observe the curative effect of the treatment of the cetuximab |
|
| RT concurrent with TP | Experimental | Selected 60 patients with locally advanced squamous cell carcinoma of the head and neck. They will be randomized to concurrent chemoradiotherapy versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy. To observe the curative effect of concurrent radiotherapy and chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug |
| ||
| radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 13 months | |
| incidence of oral mucositis | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 5 years | |
| Overall response rate after induction chemotherapy | 1 month |
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Inclusion Criteria:
Histologically or cytologically confirmed first diagnosis of locally advanced squamous cell carcinoma of the head and neck
Imaging (MRI, CT, bone scan) stage Ⅲ、Ⅳa (T1-2N2M0、T3N0-2M0、T4N0-2M0) (2010AJCC staging criteria)
18 years of age or older
Presence of at least 1 measurable lesion according to RECIST version1.1
DON'T accept surgery, chemotherapy or irradiation before trial entry
Eastern Cooperative Oncology Group(ECOG) 0 or 1
Expected survival period over 6months
Before RT randomization, bone marrow and liver and kidney function in patients with meet the following criteria:
Signed written informed consent before any trail-related activities are carried out.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenzhou Yang, Doctor | Contact | +86-13883270881 | yangzz1970@163.com |
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|
| Docetaxel | Drug |
|
| Cisplatin | Drug |
|
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D011827 | Radiation |
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D055585 | Physical Phenomena |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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