Cisplatin Plus Docetaxel Versus Cetuximab, Cisplatin, and Docetaxel in Metastatic Nasopharyngeal Carcinoma
Phase Ⅲ Randomized Trial of Cisplatin Plus Docetaxel Versus Cetuximab, Cisplatin, and Docetaxel Induction Chemotherapy Followed by Concurrent Chemoradiation in Previously Untreated Patients Metastatic Nasopharyngeal Carcinoma
1 other identifier
interventional
120
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 10, 2015
CompletedFirst Posted
Study publicly available on registry
December 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedDecember 17, 2015
December 1, 2015
8 years
December 10, 2015
December 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Event-free Survival
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.
Disease-free Survival
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
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
every 6 weeks, up to 5 years.
Study Arms (2)
cisplatin and docetaxel
ACTIVE COMPARATORInduction 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
EXPERIMENTALInduction 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.
Interventions
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.
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.
75mg/m\^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.
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.
60-66 Gy if complete response or 66-70 Gy if partial response following induction chemotherapy.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed nasopharyngeal carcinoma
- 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
You may not qualify if:
- Prior radiotherapy of target lesions
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- Chinese Southwest Oncology Groupcollaborator
Study Sites (10)
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350014, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Guangxi Cancer Hospital
Nanning, Guangxi, 530021, China
Union Hospital,Tongji Medical College of Huazhong University of Science ＆ Technology
Wuhan, Hubei, 430022, China
Tongji Hospital,Tongji Medical College of Huazhong University of Science ＆ Technology
Wuhan, Hubei, 430030, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610047, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Related Publications (1)
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.
PMID: 32637360DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tongyu Lin, MD
Sun Yat-sen University
- PRINCIPAL INVESTIGATOR
Taixiang Lu, MD
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Director of Medical Oncology Department, Sun Yat-sen University Cancer Center
Study Record Dates
First Submitted
December 10, 2015
First Posted
December 17, 2015
Study Start
January 1, 2015
Primary Completion
January 1, 2023
Last Updated
December 17, 2015
Record last verified: 2015-12