Nasopharyngeal Carcinoma
Conditions
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.
Interventions
DRUGCetuximab
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.
DRUGCisplatin
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.
DRUGDocetaxel
75mg/m\^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.
DRUGCapecitabine
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.
RADIATIONRadiotherapy
60-66 Gy if complete response or 66-70 Gy if partial response following induction chemotherapy.
Sponsors
Chinese Southwest Oncology Group
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| 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 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. |
| Overall response rate | every 6 weeks, up to 5 years. | 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. |
Countries
China
Contacts
Primary ContactHe Huang, MD
Outcome results
None listed