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| Name | Class |
|---|---|
| Chinese Southwest Oncology Group | UNKNOWN |
This is a Phase Ⅲ randomized, controlled, multi-center, trial comparing cisplatin plus docetaxel to cetuximab, cisplatin, and docetaxel induction chemotherapy followed by concurrent chemoradiation in previously untreated patients metastatic nasopharyngeal carcinoma (mNPC) to determine whether the addition of cetuximab to induction chemotherapy and chemoradiation could improve therapeutic efficacy in mNPC, and investigate predictive and prognostic factors for mNPC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cisplatin and docetaxel | Active Comparator | Induction chemotherapy: Patients receive cisplatin and docetaxel intravenously on day 1 repeated every 3 weeks for 6 cycles. Concurrent chemoradiation: Patients who achieve complete response or partial response receive radiotherapy for primary and/or metastatic lesions with concurrent cisplatin 30mg/m^2 intravenously every week. Maintenance treatment: Capecitabine will be given at a dose of 1000mg/m^2 orally twice a day starting on day 1 and continuing for days 1 to 14 of each 21 day cycle for at least 2 years or until progression. |
|
| cetuximab, cisplatin, and docetaxel | Experimental | Induction chemotherapy: Patients receive cetuximab 400mg/m^2 intravenously over at least 120 minutes on day 1 followed by 250 mg/m^2 intravenously over at least 60 minutes every week. Cisplatin and docetaxel will be administered intravenously on day 2 repeated every 3 weeks for 6 cycles. Concurrent chemoradiation: Patients who achieve complete response or partial response receive radiotherapy for primary and/or metastatic lesions with concurrent cetuximab 250mg/m^2 intravenously followed by cisplatin 30mg/m^2 intravenously every week. Maintenance treatment: Capecitabine will be given at a dose of 1000mg/m^2 orally twice a day starting on day 1 and continuing for days 1 to 14 of each 21 day cycle for at least 2 years or until progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug | 400 mg/m^2 intravenously on day 1,then 250 mg/m^2 intravenously every week of each 21 day cycle for 6 cycles of induction chemotherapy.250 mg/m^2 intravenously every week concurrent with radiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival was defined as the time from date of randomization until the date of first documented progression, date of death from any cause, or date of last assessment, whichever came first. All eligible and treated patients were included in the analysis. | From date of randomization until the date of first documented progression, date of death from any cause, or date of last assessment, whichever came first, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival | Event-free survival was defined as the time from date of randomization until the date of first documented progression, date of death from any cause, date of introduction of a new treatment without evidence of progression or relapse, or date of last assessment, whichever came first. All eligible and treated patients were included in the analysis. | From date of randomization until the date of first documented progression, date of death from any cause, date of introduction of a new treatment, or date of last assessment, whichever came first, assessed up to 5 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| He Huang, MD | Contact | +86-20-87343363 | huanghe@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Tongyu Lin, MD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Taixiang Lu, MD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32637360 | Derived | Zhang M, Huang H, Li X, Huang Y, Chen C, Fang X, Wang Z, Guo C, Lam S, Fu X, Hong H, Tian Y, Lu T, Lin T. Long-Term Survival of Patients With Chemotherapy-Naive Metastatic Nasopharyngeal Carcinoma Receiving Cetuximab Plus Docetaxel and Cisplatin Regimen. Front Oncol. 2020 Jun 19;10:1011. doi: 10.3389/fonc.2020.01011. eCollection 2020. |
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| Cisplatin | Drug | 75mg/m^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.30 mg/m^2 intravenously every week concurrent with radiotherapy. |
|
| Docetaxel | Drug | 75mg/m^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy. |
|
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| Capecitabine | Drug | 1000mg/m^2 orally twice a day, days 1 to 14 of each 21 day cycle for at least 2 years or until progression following concurrent chemoradiation. |
|
|
| Radiotherapy | Radiation | 60-66 Gy if complete response or 66-70 Gy if partial response following induction chemotherapy. |
|
| Disease-free Survival | Disease-free survival was defined as the time from date of attainment a complete response until the date of first documented relapse, date of death from NPC or treatment-related toxicities, or date of last assessment, whichever came first. All eligible and treated patients were included in the analysis. | From date of attainment a complete response until the date of first documented relapse, date of death from NPC or treatment-related toxicities, or date of last assessment, whichever came first, assessed up to 5 years. |
| Overall Survival | Overall survival was defined as the time from randomization until the date of death from any cause, or date of last assessment, whichever came first. All eligible and treated patients were included in the analysis. | From date of randomization until the date of death from any cause, or date of last assessment, whichever came first, assessed up to 5 years. |
| Overall response rate | Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Overall response rate= complete response + partial response. Tumor measurements were performed using physical examination, computer tomography (CT) or Positron Emission Tomography-Computer Tomography (PET-CT) scans and Magnetic Resonance Imaging （MRI） scans, which were consist with baseline measurements methods. | every 6 weeks, up to 5 years. |
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
|
| The First Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
|
| Guangxi Cancer Hospital | Recruiting | Nanning | Guangxi | 530021 | China |
|
| Union Hospital,Tongji Medical College of Huazhong University of Science ＆ Technology | Recruiting | Wuhan | Hubei | 430022 | China |
|
| Tongji Hospital,Tongji Medical College of Huazhong University of Science ＆ Technology | Recruiting | Wuhan | Hubei | 430030 | China |
|
| Jiangsu Cancer Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| Sichuan Cancer Hospital | Recruiting | Chengdu | Sichuan | 610047 | China |
|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | 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 |
|---|---|
| D000068818 | Cetuximab |
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| D000069287 | Capecitabine |
| D011878 | Radiotherapy |
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013812 | Therapeutics |
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