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

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02633176
• Other study ID #: CSWOG0103
• Status: Recruiting
• Phase: Phase 3
• First received: December 10, 2015
• Last updated: December 14, 2015
• Start date: January 2015

Study information

• Verified date: December 2015
• Source: Sun Yat-sen University
• Contact: He Huang, MD
• Phone: +86-20-87343363
• Email: huanghe[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed nasopharyngeal carcinoma

• Untreated metastatic nasopharyngeal carcinoma (stage ?C according to the 7th American Joint Committee on Cancer staging system and stage ?B 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 ? to ? 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Cetuximab
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.
• Cisplatin
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.
• Docetaxel
75mg/m^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.
• Capecitabine
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.

Radiation:
• Radiotherapy
60-66 Gy if complete response or 66-70 Gy if partial response following induction chemotherapy.

Locations

Country	Name	City	State
China	Sichuan Cancer Hospital	Chengdu	Sichuan
China	Fujian Provincial Cancer Hospital	Fuzhou	Fujian
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Guangxi Cancer Hospital	Nanning	Guangxi
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Tongji Hospital,Tongji Medical College of Huazhong University of Science & Technology	Wuhan	Hubei
China	Union Hospital,Tongji Medical College of Huazhong University of Science & Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Chinese Southwest Oncology Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Event-free Survival	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.	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.	No
Secondary	Disease-free Survival	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.	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.	No
Secondary	Overall Survival	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.	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.	No
Secondary	Overall response rate	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.	every 6 weeks, up to 5 years.	No