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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Trial Comparing Induction Gemcitabine and Cisplatin Plus Intensity-modulated Radiotherapy With Concurrent Cisplatin Plus Intensity-modulated Radiotherapy in Patients With Locoregionally A

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 Summary:

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.


Sponsor: Sun Yat-sen University

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: May 28, 2015
Date Started: June 2015
Date Completion: June 2020
Last Updated: April 15, 2016
Last Verified: April 2016