Brief Title
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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progression-free survival
Secondary Outcome
Event-free Survival
Condition
Nasopharyngeal Carcinoma
Intervention
Cetuximab
Study Arms / Comparison Groups
cisplatin and docetaxel
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
120
Start Date
January 2015
Primary Completion Date
January 2023
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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Tongyu Lin, MD, +86-20-87343363, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02633176
Organization ID
CSWOG0103
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Collaborators
Chinese Southwest Oncology Group
Study Sponsor
Tongyu Lin, MD, Principal Investigator, Sun Yat-sen University
Verification Date
December 2015