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| Name | Class |
|---|---|
| People's Hospital of Baise | UNKNOWN |
| Second Affiliated Hospital of Guangzhou Medical University | OTHER |
| People's Hospital of Guangxi Zhuang Autonomous Region | OTHER |
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Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. This is a multi-center, randomized controlled trial, with the purpose to evaluate the therapeutic efficacy and safety of nimotuzumab combined with induction chemotherapy plus chemoradiation and adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Nimotuzumab arm | Experimental | Patients will receive induction chemotherapy with nimotuzumab (200mg/w,weekly plus gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 2 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent nimotuzumab (200mg/w,weekly, 6-7 weeks) and cisplatin (100mg/m2,every 3 weeks for 3cycles )will be administered during IMRT. After 4-6 weeks of the completion of IMRT, adjuvant nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles. |
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| Control | Active Comparator | Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 2 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent nimotuzumab (200mg/w,weekly, 6-7 weeks) and cisplatin (100mg/m2,every 3 weeks for 3cycles )will be administered during IMRT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | Drug: Nimotuzumab Experimental: Nimotuzumab arm Induction chemotherapy:Nimotuzumab 200mg will be given weekly for 6 cycles, started on day 1 of induction chemotherapy. Concurrent chemotherapy: Nimotuzumab 200mg/week in concurrent with IMRT. Adjuvant therapy: Nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles. Active Comparator: Control Nimotuzumab 200mg/week in concurrent with IMRT . |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival(OS) | Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.OS will be measured by the Method of Kaplan and Meier. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor control probability (TCP) | Tumor control probability is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Lu, MD | Contact | +8607723815405 | 1786734840@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Lu, MD | Fourth Affiliated Hospital of Guangxi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Hospital of Baise | Recruiting | Baise City | Guangxi | 533000 | China |
Complete de-identified patient data set
For 2 years started from 12 months after publication of the primary trial report.
Authoritative researchers who provide a methodologically sound proposal for individual participant data meta-analysis.
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| Guilin Medical University, China |
| OTHER |
| LiuZhou People's Hospital | OTHER |
| The First People's Hospital of Qinzhou | UNKNOWN |
| Wuzhou Red Cross Hospital | OTHER |
| Youjiang Medical College for Nationalities | OTHER |
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| Gemcitabine | Drug | Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 2 cycles |
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| Cisplatin | Drug | Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles. Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles. |
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| Intensity-modulated radiotherapy | Radiation | Definitive IMRT of 68-78 Gy, 30-33 fractions, 5 fractions/week, 1 fraction/day |
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| Disease-free survival(DFS) |
DFS is defined as the time from randomization to the first documented disease progression or death due to disease progression per RECIST 1.1. DFS will be measured by the Method of Kaplan and Meier. |
| 5 years |
| Locoregional failure-free survival(LRRFS) | LRRFS is defined as the time from randomization to the date of locoregional relapse per RECIST 1.1. LRRFS will be measured by the Method of Kaplan and Meier. | 5 years |
| Distant Metastasis-free survival(DMFS) | DMFS is defined as the time from randomization to the date of first distant metastasis. DMFS will be measured by the Method of Kaplan and Meier. | 5 years |
| Incidence rate of investigator-reported adverse events (AEs) | Analysis of investigator-reported adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0 and radiation therapy oncology group (RTOG) toxicity criteria. | 5 years |
| Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) | Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment. | 5 years |
| Affiliated Hospital of Youjiang Medical University for Nationalities | Recruiting | Baise City | Guangxi | 533099 | China |
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| Guilin Medical University, China | Recruiting | Guilin | Guangxi | 541000 | China |
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| Nanxishan Hospital of Guangxi Zhuang Autonomous Region | Recruiting | Guilin | Guangxi | 541000 | China |
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| the Fourth Affiliated Hospital of Guangxi Medical University | Recruiting | Liuzhou | Guangxi | China |
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| Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Nanjing | Guangxi | 530000 | China |
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| The First People's Hospital of Qinzhou | Recruiting | Qinzhou | Guangxi | 535000 | China |
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| Wuzhou Red Cross Hospital | Recruiting | Wuzhou | Guangxi | 543000 | China |
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| Liuzhou People's Hospital | Recruiting | Liuzhou | Other (Non U.s.) | 545000 | China |
|
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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