Clinical trial NCT02633176: Cisplatin Plus Docetaxel Versus Cetuximab, Cisplatin, and Docetaxel in Metastatic Nasopharyngeal Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Chinese Southwest Oncology Group
First posted: 2015-12-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 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:
measure: Event-free Survival
timeFrame: 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.
measure: Disease-free Survival
timeFrame: 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.
measure: Overall Survival
timeFrame: 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.
measure: Overall response rate
timeFrame: every 6 weeks, up to 5 years.
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Nanning
country: China
facility: Guangxi Cancer Hospital
state: Guangxi
city: Wuhan
country: China
facility: Union Hospital,Tongji Medical College of Huazhong University of Science ＆ Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital,Tongji Medical College of Huazhong University of Science ＆ Technology
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Sun Yat-sen University
name: Tongyu Lin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-sen University
name: Taixiang Lu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.