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| Name | Class |
|---|---|
| Biotech Pharmaceutical Co., Ltd. | OTHER |
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The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.
Locoregionally advanced squamous cell carcinoma of the head and neck(LA-SCCHN) poses one of the most complex management challenges. This stage of disease is still potentially curable, but requires combined-modality therapy. Recent studies have showed that induction chemotherapy（neoadjuvant）reduced the 3-year distant relapse rate. Concurrent chemoradiotherapy(CCRT), on the other hand, has demonstrated a significant and consistent benefit in local control rates, but its impact on distant failure is inconsistent. Nimotuzumab is a novel EGFR-targeting monoclonal antibody that has the potential.to be used as a single agent or as a radio- and chemotherapy sensitizer for the treatment of SCCHN. Thus, investigators conducted a randomized, multicenter phaseⅡ study to compare the efficiency and safety of adding nimotuzumab to neoadjuvant and CCRT with neoadjuvant and CCRT in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant and CCRT | Active Comparator |
| |
| Neoadjuvant and CCRT and Nimotuzumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel and cisplatin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system. | 3 months after all the treatment ending |
| The Number of Participants with Adverse Events | Record the Number of participants with adverse events and the Grades of the AE according to CTCAE v3.0 as the two measure of safety. | Participants will be followed during the treatment and 3 months after all the treatment ending ,an expected average of 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | From date of randomization until the date of death from any cause,assessed up to 5 years | |
| Progression-Free Survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi J Lang, M.D. | Radiotherapy department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gansu Province Medical Science Institute | Active, not recruiting | Lanzhou | Gansu | 730050 | China | |
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| IMRT | Radiation | IMRT is administered with chemotherapy from week 7 to week 13
|
|
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| Nimotuzumab | Biological | Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13~14 weeks |
|
| Evaluate the Local control Rate in 1 to 5 years. | To evaluate each year until 5 years later | Participants will be followed every year for the duration of 5 years |
| Tumor-Free Survival | From date of randomization until the date of first documented occurrence of primary, neck, distant relapse,assessed up to 5 years |
| Non-metastatic Rate | The time from randomization until distant relapse occur,assessed up to 5 years |
| Guangxi Tumor Hospital |
| Active, not recruiting |
| Nanning |
| Guangxi |
| 530021 |
| China |
| GuiZhou Cancer Hospital | Active, not recruiting | Guiyang | Guizhou | 550004 | China |
| Neimenggu Tumor Hospital | Active, not recruiting | Baotou | Neimenggu | 014030 | China |
| The Tumor Affiliated Hospital of Ningxia Medical University General Hospita | Active, not recruiting | Yinchuan | Ningxia | 750004 | China |
| Qinghai Five Hospital | Active, not recruiting | Xining | Qinghai | China |
| ShanXi Cancer Hospital | Active, not recruiting | Xian | Shanxi | 710061 | China |
| Xijing Hospital | Active, not recruiting | Xi’an | Shanxi | 710032 | China |
| The Second People's Hospital of Sichuan | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| West China Hospital, Sichuan University | Active, not recruiting | Chengdu | Sichuan | 610041 | China |
| Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Active, not recruiting | Chongqing | Sichuan | 400042 | China |
| Xinjiang tumor hospital, The Third Affiliated Hospital of Xinjiang Medical University | Active, not recruiting | Ürümqi | Xinjiang | 830000 | China |
| Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University | Active, not recruiting | Kunming | Yunnan | 652100 | China |
| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| D007012 | Hypopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| C501466 | nimotuzumab |
| ID | Term |
|---|---|
| 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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