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Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC (NPC)

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: NCT01854203
Recruitment Status : Unknown
Verified July 2013 by Jian-jun Li, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : May 15, 2013
Last Update Posted : July 30, 2013
Sponsor:
Information provided by (Responsible Party):
Jian-jun Li, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE May 10, 2013
First Posted Date  ICMJE May 15, 2013
Last Update Posted Date July 30, 2013
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2013)
  • Overall survival [ Time Frame: 3-year ]
    Overall survival is calculated from randomization to death from any cause.
  • Failure-free survival [ Time Frame: 3-year ]
    Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
  • Locoregional failure-free survival [ Time Frame: 3-year ]
    the latency to the first local failure
  • Distant failure-free survival [ Time Frame: 3-year ]
    The latency to the first remote failure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2013)
Difference in the complete response rates between the two treatment arms [ Time Frame: 12 weeks after the completion of therapy ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 13, 2013)
Rates of toxicity [ Time Frame: 3-years ]
Rates of toxicity will also be compared. Rates will be compared by the chi-square test.The Chemotherapy toxicity include thrombocytopenia, leukocytopenia , anemia, granulocytopenia,damage to hepatic function, damage to renal function,constipation, diarrhea,vomiting and rash. The radiotherapy toxicities include mucositis, radiation dermatitis,dysphagia, xerostomia, skin fibrosis, trismus, hearing loss ane cranial neuropathy.
Original Other Pre-specified Outcome Measures
 (submitted: May 14, 2013)
Rates of toxicity [ Time Frame: 3-years ]
Rates of toxicity will also be compared. Rates will be compared by the chi-square test.
 
Descriptive Information
Brief Title  ICMJE Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC
Official Title  ICMJE Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated Radiotherapy With or Without Concurrent Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma
Brief Summary Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.
Detailed Description The purpose of this study is to compare gemcitabine plus cisplatin induction chemotherapy combine intensity-modulated radiotherapy with or without concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to reevaluate the value of concurrent cisplatin when 4 cycles induction chemotherapy (gemcitabine+cisplatin) and IMRT is used.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE
  • Drug: Inductive chemotherapy + concurrent cisplatin and IMRT
    Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2,on day 1) repeated every week for 6 cycles during radiotherapy.
    Other Name: Gemcitabine and cisplatin
  • Drug: Inductive chemotherapy + IMRT
    Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.
    Other Name: Gemcitabine and cisplatin
Study Arms  ICMJE
  • Experimental: IInductive chemotherapy + concurrent cisplatin and IMRT
    Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30 mg/m2,on day 1) repeated every weeks for 6 cycles during radiotherapy.
    Intervention: Drug: Inductive chemotherapy + concurrent cisplatin and IMRT
  • Experimental: Inductive chemotherapy + IMRT
    Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.
    Intervention: Drug: Inductive chemotherapy + IMRT
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 14, 2013)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO 2005) histologically type).
  • A Karnofsky performance status of at least 80;
  • Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III:T1-2N2M0, T3N0-2M0 Stage IVa:T4N0-2M0 Stage IVb:Any T、N3.
  • Adequate marrow: a WBC ≥3.5×109 l-1; a platelet count ≥100×109 l-1; and hemoglobin levels ≥100 g/l.
  • Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
  • Adequate renal function: a creatinine clearance rate of at least 60 mL/min.
  • Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

  • WHO Type keratinizing squamous cell carcinoma.
  • Age >65 years or <18 years.
  • Distant metastasis,
  • Treatment with palliative intent.
  • Pregnancy or lactation.
  • a history of previous radiotherapy in the nasopharyngeal region or previous chemotherapy.
  • history of renal disease, unstable cardiac disease requiring treatment.
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 NCT01854203
Other Study ID Numbers  ICMJE ChiECRCT-2013003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jian-jun Li, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: yong Su, M.D. Sun Yat-sen University
Principal Investigator: Janjun Li, M.D. Sun Yat-sen University
Principal Investigator: Lizhi Liu, M.D. Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date July 2013

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