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The Role of Induction Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma in the Era of IMRT

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: NCT02460887
Recruitment Status : Active, not recruiting
First Posted : June 3, 2015
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Pei-Yu Huang, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE May 28, 2015
First Posted Date  ICMJE June 3, 2015
Last Update Posted Date May 13, 2019
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2015)
Failure-free survival [ Time Frame: 2 years ]
Failure-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02460887 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2019)
  • Overall survival [ Time Frame: 2 years ]
    Overall survival is calculated from randomization to death from any cause.
  • Locoregional failure-free survival [ Time Frame: 2 years ]
    Locoregional failure-free survival is calculated from randomization to the first locoregional failure.
  • Distant failure-free survival [ Time Frame: 2 years ]
    Distant failure-free survival is calculated from randomization to the first remote failure.
  • Overall response rate [ Time Frame: 3 months after completion of IMRT ]
    Overall response rate at 3 months after completion of IMRT
  • Number of participants with adverse events [ Time Frame: 2 years ]
    Incidence of acute and late toxicity
  • Quality of life during treatment [ Time Frame: During whole chemotherapy and IMRT treatment.For experimental arm, an expected average of 12 weeks; for active comparator arm, an expected average of 6 weeks. ]
    Quality of life is measured by FACIT questionnaire.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2015)
  • Overall survival [ Time Frame: 2 years ]
    Overall survival is calculated from randomization to death from any cause.
  • Locoregional failure-free survival [ Time Frame: 2 years ]
    Locoregional failure-free survival is calculated from randomization to the first locoregional failure.
  • Distant failure-free survival [ Time Frame: 2 years ]
    Distant failure-free survival is calculated from randomization to the first remote failure.
  • Overall response rate [ Time Frame: 3 months after completion of IMRT ]
  • Number of participants with adverse events [ Time Frame: 2 years ]
    Incidence of acute and late toxicity
  • Quality of life during treatment [ Time Frame: During whole chemotherapy and IMRT treatment.For experimental arm, an expected average of 12 weeks; for active comparator arm, an expected average of 6 weeks. ]
    Quality of life is measured by FACIT questionnaire.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of Induction Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma in the Era of IMRT
Official Title  ICMJE A Randomized Trial Comparing Induction Gemcitabine and Cisplatin Plus Intensity-modulated Radiotherapy With Concurrent Cisplatin Plus Intensity-modulated Radiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Brief Summary The purpose of this study is to verify that induction gemcitabine and cisplatin plus intensity-modulated radiotherapy (IMRT) is non-inferior to concurrent weekly cisplatin plus IMRT for patients with locoregionally advanced nasopharyngeal carcinoma (NPC).
Detailed Description

Patients with non-keratinizing NPC T1-4N2-3或T3-4N0-1M0 (UICC/AJCC 7th edition) are randomly assigned to receive induction chemotherapy or CCRT alone. Patients in experimental group receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before intensity-modulated radiotherapy (IMRT). Patients in control group receive IMRT concurrently with weekly cisplatin 40 mg/m² up to 7cycles.

IMRT is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.

Our primary endpoint is failure-free survival (FFS). Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

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: Gemcitabine
    Experimental arm: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before IMRT.
  • Drug: cisplatin
    Experimental arm: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before IMRT.
    Other Name: DDP
  • Drug: cisplatin
    Active Comparator arm: Patients receive weekly cisplatin 40 mg/m² up to 7cycles during IMRT.
    Other Name: DDP
  • Radiation: Intensity-modulated Radiotherapy
    Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.
    Other Name: IMRT
Study Arms  ICMJE
  • Experimental: Experimental
    Induction chemotherapy+IMRT gemcitabine and cisplatin regimen Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT).
    Interventions:
    • Drug: Gemcitabine
    • Drug: cisplatin
    • Radiation: Intensity-modulated Radiotherapy
  • Active Comparator: Active Comparator
    IMRT and concurrent cisplatin Patients receive intensity modulated-radiotherapy (IMRT), concurrently with weekly cisplatin 40 mg/m² up to 7cycles.
    Interventions:
    • Drug: cisplatin
    • Radiation: Intensity-modulated Radiotherapy
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 9, 2019)
236
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2015)
92
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (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).
  • Tumor staged as T1-4N2-3或T3-4N0-1M0 (according to the 7th AJCC edition).
  • Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
  • Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL.
  • Adequate liver function: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤1.5×ULN.
  • Adequate renal function: creatinine clearance ≥ 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 or basaloid squamous cell carcinoma.
  • Treatment with palliative intent.
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
  • Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
  • History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
  • Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  • Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.
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 NCT02460887
Other Study ID Numbers  ICMJE Sun Yat-sen University HPY
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pei-Yu Huang, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pei-Yu Huang, M. D., Ph.D. Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date May 2019

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