Clinical Trial: Study of Neoadjuvant Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Randomized Phase Ⅱ Trial of Induction Chemotherapy Using Gemcitabine and Cisplatin in Concurrence With Intensity-modulated Radiotherapy for Locoregionally Advanced Nasophar

Brief Summary: The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of induction chemotherapy using gemcitabine and cisplatin in NPC patients.

Detailed Summary: Patients presented with non-keratinizing NPC and stage Ⅲ-Ⅳb T3-4N1M0/TxN2-3M0 are randomly assigned to receive induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy (investigational arm) or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical Intensity modulated radiation therapy (Trilogy, Varian), and cisplatin (40mg/m2) every weeks for six cycles during radiotherapy. Radiation is delivered to GTV at 70 Gy in 30 fractions, CTV1 at at 60 Gy in 30 fractions and CTV2 at 54 Gy in 30 fractions. Patients in the investigational arm receive gemcitabine (1000mg/m2 on day 1,8) and cisplatin (20mg/m2 on day 1-4) every three weeks for two cycles before the radiotherapy. The primary end point is response rates after radiotherapy, failure-free survival (FFS) and toxic effects and treatment compliance. Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS). All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.
Sponsor: First People's Hospital of Foshan

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival [ Time Frame: 3-year ]
    Overall survival is calculated from randomization to death from any cause.
  • 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
  • The initial response rates after treatments [ Time Frame: 16 weeks after completion of radiotherapy ]


Original Secondary Outcome: Same as current

Information By: First People's Hospital of Foshan

Dates:
Date Received: August 15, 2011
Date Started: November 2011
Date Completion: December 2015
Last Updated: March 6, 2014
Last Verified: March 2014