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Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT02111460
Recruitment Status : Recruiting
First Posted : April 11, 2014
Last Update Posted : September 13, 2016
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Guangdong Provincial People's Hospital
Information provided by (Responsible Party):
Ming-Yuan Chen, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE April 9, 2014
First Posted Date  ICMJE April 11, 2014
Last Update Posted Date September 13, 2016
Study Start Date  ICMJE October 2013
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2016)
Overall survival [ Time Frame: 2 years ]
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
Progress-free survival [ Time Frame: 2 years ]
Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
Change History Complete list of historical versions of study NCT02111460 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2016)
  • Progress-free survival [ Time Frame: 2 years ]
    Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
  • Complete Response (CR) [ Time Frame: after the completion of the chemoradiotherapy treatment (up to 9 weeks) ]
    CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
  • Determine the toxic effects, both quantitatively and qualitatively, and quality of life (QoL) of these regimens in these patients. [ Time Frame: 4 weeks ]
    Administration and Monitoring Patients will be evaluated in the clinic and eligibility and informed consent obtained. Patients will be monitored for clinical toxicity by standard NIH criteria. QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) and EORTC QLQ Head and Neck. A time period of 4 weeks will constitute the time for clinical safety monitoring.
  • Complete Response (CR) [ Time Frame: after the completion of the chemoradiotherapy treatment (up to 9 weeks) ]
    CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
  • Overall Survival(OS) [ Time Frame: 2 years ]
    The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
  • Locoregional Relapse-Free Survival(LRRFS) [ Time Frame: 2 years ]
    The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.
  • Distant Metastasis-Free Survival (DMFS) [ Time Frame: 2 years ]
    The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
  • Cost-effectiveness analysis [ Time Frame: completion of chemoradiotherapy (up to 9 weeks) ]
    The determination of cost, including direct cost drug fees, inspection fees, expenses and nursing cost; cost-effectiveness analysis, such as cost-effectiveness ratio (ratio of the direct cost and short - and long-term curative effect) and incremental cost-effectiveness ratio (i.e., increasing costs and increase short or long-term efficacy ratio).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma
Official Title  ICMJE Multicentre Randomization Clinic Trial of Systemic Chemotherapy Combined With Loco-regional Radiotherapy vs. Chemotherapy Alone for Initially Untreated Distant Metastatic Nasopharyngeal Carcinoma With Chemosensitivity
Brief Summary This is a randomized parallel control trial to evaluate whether radical loco-regional Radiotherapy can prolong survival time of initial untreated metastatic nasopharyngeal carcinoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE Radiation: Loco-regional Radiotherapy
with or without Loco-regional Radiotherapy
Study Arms  ICMJE
  • Experimental: Radiotherapy
    Systemic Chemotherapy Combined with Loco-regional Radiotherapy
    Intervention: Radiation: Loco-regional Radiotherapy
  • Active Comparator: Chemotherapy
    Chemotherapy alone without Loco-regional Radiotherapy
    Intervention: Radiation: Loco-regional Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2014)
204
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patients with initial untreated metastatic nasopharyngeal carcinoma
  • Histologic diagnosis of nasopharyngeal carcinoma
  • T1-4N0-3M1,IVC(according to the 7th AJCC edition)
  • Aged between 18 and 65 years
  • KPS≥70
  • The therapeutic effect evaluation is CR or PR accomplished three course of cisplatin and 5-Fu
  • Voluntary to participate and sign informed consent document

Exclusion Criteria:

  • The patients suffered from serious neurologic disease
  • Clinically significant cardiac, heart function less than or equal to 3 level
  • Clinically significant respiratory disease,lung function less than or equal to 3 level
  • Blood routine examination: WBC<3×109/L, Hemoglobin<90g/L, platelet count<75×109/L
  • Abnormal liver function: total bilirubin or ALT or AST>2×ULN
  • Abnormal renal function:serum creatinine>1.5×ULN
  • Pregnant or lactating women
  • The therapeutic effect evaluation is SD or PD accomplished three course of cisplatin and 5-Fu
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiong Zou, MD 86-20-8734-2422 zouxiong@sysucc.org.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02111460
Other Study ID Numbers  ICMJE SYSUCC5010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ming-Yuan Chen, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE
  • First Affiliated Hospital, Sun Yat-Sen University
  • Guangdong Provincial People's Hospital
Investigators  ICMJE
Principal Investigator: Ming y Chen, MD,Phd Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP