Cisplatin Plus Docetaxel Versus Cetuximab, Cisplatin, and Docetaxel in Metastatic Nasopharyngeal Carcinoma
NCT ID: NCT02633176
Last Updated: 2015-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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cisplatin and docetaxel
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.
Cisplatin
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
75mg/m\^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.
Capecitabine
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
60-66 Gy if complete response or 66-70 Gy if partial response following induction chemotherapy.
cetuximab, cisplatin, and docetaxel
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.
Cetuximab
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.
Cisplatin
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
75mg/m\^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.
Capecitabine
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
60-66 Gy if complete response or 66-70 Gy if partial response following induction chemotherapy.
Interventions
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Cetuximab
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.
Cisplatin
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
75mg/m\^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.
Capecitabine
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
60-66 Gy if complete response or 66-70 Gy if partial response following induction chemotherapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Untreated metastatic nasopharyngeal carcinoma (stage ⅣC according to the 7th American Joint Committee on Cancer staging system and stage ⅣB according to the Chinese 2008 staging system for nasopharyngeal carcinoma)
* Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of at least 6 months
* Absolute neutrophil count (ANC) \>=1.5×10\^9/L
* Platelets \>= 80×10\^9/L
* Hemoglobin \>= 90 g/l
* Bilirubin \<= 1.5 × upper limit of normal (ULN)
* Aminopherases ( alanine transaminase and aspartate aminotransferase) \<= 2.5 × ULN (without liver metastasis) or \<= 5.0 × ULN (with liver metastasis)
* Creatinine \<=ULN
* International normalized ratio (INR) of prothrombin time (PT) \<= 1.5 × ULN
* The pregnancy tests of women of childbearing potential should be negative before treatment
* Women of childbearing potential and sexually active males must adopt efficient contraception methods while on treatment and for six months after the completion of the treatment
* Patients should understand and are willing to participate in the study. Inform consent form is supposed to obtained before treatment
Exclusion Criteria
* Prior systemic chemotherapy and/or targeted therapy
* Brain metastasis
* Concurrent other malignancies
* Severe or active infectious disease requiring systemic antibiotics or antiviral, antifungal treatment
* Active tuberculosis
* Severe cardiovascular disease, including uncontrolled hypertension, unstable angina, myocardial infarction in the past 6 months, congestive heart failure with cardiac function grade Ⅲ to Ⅳ based on New York Heart Association cardiac functional grading, serious arrhythmia, or pericardial effusion
* Co-existing mental disease that would preclude full compliance with the study
* Females are pregnant or breast feeding
18 Years
75 Years
ALL
No
Sponsors
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Chinese Southwest Oncology Group
UNKNOWN
Sun Yat-sen University
OTHER
Responsible Party
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Tongyu Lin
Vice Director of Medical Oncology Department, Sun Yat-sen University Cancer Center
Principal Investigators
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Tongyu Lin, MD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Taixiang Lu, MD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Guangxi Cancer Hospital
Nanning, Guangxi, China
Union Hospital,Tongji Medical College of Huazhong University of Science ＆ Technology
Wuhan, Hubei, China
Tongji Hospital,Tongji Medical College of Huazhong University of Science ＆ Technology
Wuhan, Hubei, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Cheng Huang, MD
Role: primary
Zhao Wang, MD
Role: primary
Mengping Zhang, MD
Role: primary
Chaoyong Liang, MD
Role: primary
Gang Wu, MD
Role: primary
Shiying Yu, MD
Role: primary
Jifeng Feng, MD
Role: primary
Xichun Hu, MD
Role: primary
Jinyi Lang, MD
Role: primary
Yuan Zhu, MD
Role: primary
References
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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.
Other Identifiers
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CSWOG0103
Identifier Type: -
Identifier Source: org_study_id