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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Cetuximab
Cisplatin
Docetaxel
Capecitabine
Radiotherapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fujian Provincial Cancer HospitalRecruiting
  • Sun Yat-sen University Cancer CenterRecruiting
  • The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting
  • Guangxi Cancer HospitalRecruiting
  • Union Hospital,Tongji Medical College of Huazhong University of Science ＆ TechnologyRecruiting
  • Tongji Hospital,Tongji Medical College of Huazhong University of Science ＆ TechnologyRecruiting
  • Jiangsu Cancer HospitalRecruiting
  • Fudan University Shanghai Cancer CenterRecruiting
  • Sichuan Cancer HospitalRecruiting
  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

cisplatin and docetaxel

cetuximab, cisplatin, and docetaxel

Arm 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.

Induction chemotherapy: Patients receive cetuximab 400mg/m^2 intravenously over at least 120 minutes on day 1 followed by 250 mg/m^2 intravenously over at least 60 minutes every week. Cisplatin and docetaxel will be administered intravenously on day 2 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 cetuximab 250mg/m^2 intravenously followed by 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
December 10, 2015
Last Updated
December 14, 2015
Sponsor
Sun Yat-sen University
Collaborators
Chinese Southwest Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT02633176
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Chinese Southwest Oncology Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cisplatin and docetaxel
Arm Type
Active Comparator
Arm 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.
Arm Title
cetuximab, cisplatin, and docetaxel
Arm Type
Experimental
Arm Description
Induction chemotherapy: Patients receive cetuximab 400mg/m^2 intravenously over at least 120 minutes on day 1 followed by 250 mg/m^2 intravenously over at least 60 minutes every week. Cisplatin and docetaxel will be administered intravenously on day 2 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 cetuximab 250mg/m^2 intravenously followed by 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.
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
75mg/m^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
60-66 Gy if complete response or 66-70 Gy if partial response following induction chemotherapy.
Primary Outcome Measure Information:
Title
Progression-free survival
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Event-free Survival
Description
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.
Time Frame
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.
Title
Disease-free Survival
Description
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.
Time Frame
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.
Title
Overall Survival
Description
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.
Time Frame
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.
Title
Overall response rate
Description
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.
Time Frame
every 6 weeks, up to 5 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
He Huang, MD
Phone
+86-20-87343363
Email
huanghe@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tongyu Lin, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Taixiang Lu, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Provincial Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng Huang, MD
Email
cheng671@sina.com
First Name & Middle Initial & Last Name & Degree
Cheng Huang, MD
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao Wang, MD
Phone
+86-20-87343694
Email
wangzhao@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
He Huang, MD
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mengping Zhang, MD
Phone
+86-20-87755766-8576
Email
zhangmp1989@163.com
First Name & Middle Initial & Last Name & Degree
Sheng Ye, MD
Facility Name
Guangxi Cancer Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chaoyong Liang, MD
Email
lmlm1995@qq.com
First Name & Middle Initial & Last Name & Degree
Xiaohua Hu, MD
Facility Name
Union Hospital,Tongji Medical College of Huazhong University of Science ＆ Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Wu, MD
Email
xhzlwg@163.com
First Name & Middle Initial & Last Name & Degree
Gang Wu, MD
Facility Name
Tongji Hospital,Tongji Medical College of Huazhong University of Science ＆ Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiying Yu, MD
Email
syyu@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Shiying Yu, MD
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jifeng Feng, MD
Email
fjif@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Jifeng Feng, MD
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xichun Hu, MD
Email
xchu2009@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xichun Hu, MD
Facility Name
Sichuan Cancer Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610047
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinyi Lang, MD
Email
langjy610@163.com
First Name & Middle Initial & Last Name & Degree
Jinyi Lang, MD
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Zhu, MD
Email
zhuyuan63@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yuan Zhu, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32637360
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.
Results Reference
derived

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

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