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Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01540136
Recruitment Status : Completed
First Posted : February 28, 2012
Last Update Posted : October 28, 2016
Sponsor:
Collaborators:
Guangzhou Medical University
The First Affiliated Hospital of Guangdong Pharmaceutical University
Meizhou City Hospital Of Guangdong Provience
Information provided by (Responsible Party):
Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE February 22, 2012
First Posted Date  ICMJE February 28, 2012
Last Update Posted Date October 28, 2016
Study Start Date  ICMJE February 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2013)
  • 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.
  • Anti-neoplasms sensitization effects of chemotherapy to radiotherapy [ Time Frame: radiotherapy in 20Gy、40Gy、70Gy ]
    Tumor response will be evaluated by physical examination and nasopharyngoscopy when radiotherapy in 20Gy、40Gy、70Gy.
  • Cost-effectiveness analysis [ Time Frame: completion of chemoradiotherapy ]
    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).
  • Correlate effects of CCRT with biomarkers of response and predictors of long-term outcome [ Time Frame: before chemoradiotherapy and after chemoradiotherapy ]
    Early identification of patients who will have more aggressive disease soon after diagnosis has been a major goal, we will investigate the correlate effects of CCRT with biomarkers of response and predictors of long-term outcome in these patients.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2012)
  • Determine the toxic effects, both quantitatively and qualitatively, 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. 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma
Official Title  ICMJE A Randomized Phase III Non-inferiority Study of Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma
Brief Summary This is a Phase III trial to study the effectiveness of nedaplatin versus cisplatin with IMRT chemoradiotherapy in treating patients with locoregionally advanced nasopharyngeal carcinoma.
Detailed Description Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was superior to radiotherapy alone in the treatment of locoregionally advanced NPC. Cisplatin-based chemotherapy has been shown to have higher response rates in NPC than noncisplatin regimens. However, the patients' compliance was unsatisfactory because the obvious gastrointestinal toxicity of cisplatin. Nedaplatin is the new second generation platinum and it has slight gastrointestinal reaction. Our trial is in order to study the effectiveness of nedaplatin or cisplatin with intensity-modulated radiation therapy (IMRT) chemoradiotherapy in treating patients with locoregionally advanced NPC.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE
  • Drug: Nedaplatin
    Nedaplatin 100mg/m2(3 weekly),D1,D22,D43 of RT
    Other Name: NDP
  • Drug: Cisplatin
    Cisplatin 100mg/m2(3 weekly),D1,D22,D43 of RT
    Other Name: DDP
Study Arms  ICMJE
  • Experimental: Nedaplatin
    Nedplatin combine with IMRT
    Intervention: Drug: Nedaplatin
  • Active Comparator: Cisplatin
    Cisplatin combine with IMRT
    Intervention: Drug: Cisplatin
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2016)
402
Original Estimated Enrollment  ICMJE
 (submitted: February 27, 2012)
256
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
  • Original clinical staged as T1-4N1-3 or T3-4N0(according to the 7th AJCC edition)
  • No evidence of distant metastasis (M0)
  • Male and no pregnant female
  • Age between 18-65
  • WBC ≥ 4,000/mm3 and PLT ≥ 100,000/mm3
  • With normal liver function test (ALT、AST ≤ 2.5×ULN)
  • With normal renal function test (Creatinine ≤ 1.5×ULN)
  • Satisfactory performance status: Karnofsky scale (KPS)> 70
  • Without radiotherapy or chemotherapy
  • Patients must give signed informed consent

Exclusion Criteria:

  • Patients have evidence of relapse or distant metastasis
  • The presence of uncontrolled life-threatening illness
  • Receiving other ways of anti-cancer therapy
  • Receiving radiotherapy or chemotherapy
  • Pregnancy or lactation
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01540136
Other Study ID Numbers  ICMJE Sun Yat-sen University
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hai-Qiang Mai,MD,PhD, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE
  • Guangzhou Medical University
  • The First Affiliated Hospital of Guangdong Pharmaceutical University
  • Meizhou City Hospital Of Guangdong Provience
Investigators  ICMJE
Principal Investigator: HaiQiang Mai, MD,Ph.D Cancer center
PRS Account Sun Yat-sen University
Verification Date March 2013

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