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

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ClinicalTrials.gov Identifier: NCT02633176
Recruitment Status : Recruiting
First Posted : December 17, 2015
Last Update Posted : December 17, 2015
Sponsor:
Collaborator:
Chinese Southwest Oncology Group
Information provided by (Responsible Party):
Tongyu Lin, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Cetuximab Drug: Cisplatin Drug: Docetaxel Drug: Capecitabine Radiation: Radiotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2015
Estimated Primary Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: cisplatin and docetaxel

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.

Drug: 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.

Drug: Docetaxel
75mg/m^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.
Other Name: Taxotere

Drug: 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.
Other Name: Xeloda

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

Experimental: cetuximab, cisplatin, and docetaxel

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.

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.
Other Name: Erbitux

Drug: 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.

Drug: Docetaxel
75mg/m^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.
Other Name: Taxotere

Drug: 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.
Other Name: Xeloda

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




Primary Outcome Measures :
  1. Progression-free survival [ 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 ]
    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 :
  1. Event-free Survival [ 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. ]
    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.

  2. Disease-free Survival [ 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. ]
    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.

  3. Overall Survival [ 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. ]
    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.

  4. Overall response rate [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633176


Contacts
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Contact: He Huang, MD +86-20-87343363 huanghe@sysucc.org.cn

Locations
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China, Fujian
Fujian Provincial Cancer Hospital Recruiting
Fuzhou, Fujian, China, 350014
Contact: Cheng Huang, MD       cheng671@sina.com   
Principal Investigator: Cheng Huang, MD         
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Zhao Wang, MD    +86-20-87343694    wangzhao@sysucc.org.cn   
Sub-Investigator: He Huang, MD         
The First Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Mengping Zhang, MD    +86-20-87755766-8576    zhangmp1989@163.com   
Principal Investigator: Sheng Ye, MD         
China, Guangxi
Guangxi Cancer Hospital Recruiting
Nanning, Guangxi, China, 530021
Contact: Chaoyong Liang, MD       lmlm1995@qq.com   
Principal Investigator: Xiaohua Hu, MD         
China, Hubei
Union Hospital,Tongji Medical College of Huazhong University of Science & Technology Recruiting
Wuhan, Hubei, China, 430022
Contact: Gang Wu, MD       xhzlwg@163.com   
Principal Investigator: Gang Wu, MD         
Tongji Hospital,Tongji Medical College of Huazhong University of Science & Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Shiying Yu, MD       syyu@tjh.tjmu.edu.cn   
Principal Investigator: Shiying Yu, MD         
China, Jiangsu
Jiangsu Cancer Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Jifeng Feng, MD       fjif@vip.sina.com   
Principal Investigator: Jifeng Feng, MD         
China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xichun Hu, MD       xchu2009@hotmail.com   
Principal Investigator: Xichun Hu, MD         
China, Sichuan
Sichuan Cancer Hospital Recruiting
Chengdu, Sichuan, China, 610047
Contact: Jinyi Lang, MD       langjy610@163.com   
Principal Investigator: Jinyi Lang, MD         
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Yuan Zhu, MD       zhuyuan63@hotmail.com   
Principal Investigator: Yuan Zhu, MD         
Sponsors and Collaborators
Sun Yat-sen University
Chinese Southwest Oncology Group
Investigators
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Principal Investigator: Tongyu Lin, MD Sun Yat-sen University
Principal Investigator: Taixiang Lu, MD Sun Yat-sen University

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Responsible Party: Tongyu Lin, Vice Director of Medical Oncology Department, Sun Yat-sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02633176     History of Changes
Other Study ID Numbers: CSWOG0103
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Docetaxel
Capecitabine
Cetuximab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents, Immunological