Overview

Cisplatin Plus Docetaxel Versus Cetuximab, Cisplatin, and Docetaxel in Metastatic Nasopharyngeal Carcinoma

Status:
Recruiting
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Collaborator:
Chinese Southwest Oncology Group
Treatments:
Capecitabine
Cetuximab
Cisplatin
Docetaxel
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