Clinical Trial: Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Nasopharyngeal Carcinoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Locally Advanced or Metastatic Nasopharyngeal Carcinoma: a Prospective, Phase 2 Study

Brief Summary: The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy. Thus, in this study, the investigators use the combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.

Detailed Summary: The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy.However, the standard chemotherapy regimen has not been defined yet.Combination of cisplatin and fluracil is the commonly used regimen with tolerable toxicity. Recent studies have found that docetaxel has good efficacy on nasopharyngeal carcinoma patients, and capecitabine can be safely used instead of fluracil. Thus, in this study, we use the combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.
Sponsor: Sun Yat-sen University

Current Primary Outcome: overall response rate [ Time Frame: every 4 weeks,up to completion of treatment(approximately 6 months) ]

overall response rate is the sum of complete response rate and partial response rate.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • complete response rate [ Time Frame: every 4 weeks,up to completion of treatment(approximately 6 months) ]
  • 1 year progression free survival rate [ Time Frame: date from diagnosis of NPC to disease progression, or death of any cause, whichever comes first （up to 12 months）. ]
  • 1 year overall survival rate [ Time Frame: date from diagnosis of NPC to death of any cause (up to 12 months) ]
  • safety profiles (including hematologic toxicities and non-hematologic toxicities.) [ Time Frame: date from diagnosis of NPC to completion of study (about 6 months) ]
    including hematologic toxicities (eg.the incidence rate of neutropenia,thrombocytopenia, and anemia), and non-hematologic toxicities (eg.edema, diarrhea, hand-foot-syndrome).


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: February 3, 2015
Date Started: January 2008
Date Completion:
Last Updated: April 18, 2016
Last Verified: April 2016