Clinical Trial: Maintenance Treatment of Apatinib in Nasopharyngeal Carcinoma

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

Official Title: Phase II Trial of Maintenance Apatinib After Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma

Brief Summary: The study is to evaluate the efficacy and safety of Apatinib for later treatment of patients(after second-line treatment for locally recurrent or metastatic nasopharyngeal carcinoma), including overall survival (OS), distant metastasis-free survival (DMFS) and locoregional relapse-free survival (LRRFS); the relationship between EBV DNA copy number and survival after radiotherapy or radiochemotherapy; Quality of life score (QoL); evaluation of drug safety.

Detailed Summary: In locally advanced nasopharyngeal carcinoma(NPC), although fist-line therapy with radiotherapy and chemotherapy (Cisplatin/Docetaxel/5-Fu) and second-line therapy with chemotherapy has been given, patients still locally recurrence and distant metastasis. There is no standard treatment recommendation for locally recurrent or metastatic NPC who failed to second-line therapy. Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III studies of liver cancer, non small cell lung cancer and other tumors also showed apatinib has less toxicities and better tolerance. However, the clinical application of apatinib in nasopharyngeal carcinoma is still lack of evidence-based medicine. And this trial is designed to investigate the efficacy and safety of apatinib in locally recurrent or metastatic NPC.
Sponsor: Guilin Medical University, China

Current Primary Outcome: Disease-free survival (DFS) after Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma [ Time Frame: up to 2 years ]

The time from the first day of therapy to locoregional relapse, distant relapse again or tumor-related death.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival (OS) [ Time Frame: up to 2 years ]
    The time from the first day of therapy to death or last follow-up.
  • Toxicity evaluation [ Time Frame: up to 2 years ]
    Related toxicities were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.


Original Secondary Outcome: Same as current

Information By: Guilin Medical University, China

Dates:
Date Received: April 21, 2017
Date Started: January 1, 2017
Date Completion: December 30, 2019
Last Updated: April 21, 2017
Last Verified: April 2017