Clinical Trial: A Trial of Endostar in Combination With Chemotherapy of DF and Sequential Intensity Modulated Radiation Therapy for Patients With Advanced Nasopharyngeal Carcinoma

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title:

Brief Summary: Among all the head and neck tumors, nasopharyngeal carcinoma (NPC) has a high tendency of recurrence and metastasis. For the advanced NPC patients, chemoradiotherapy is the main way of treatment. Currently, chemotherapy with cisplatin (DDP) combines with 5-fluorouracil (5-FU) is the classic front line therapy for NPC. However, the abnormal richness of angiogenesis of tumor and blood supply in tissue caused by radiation therapy often decrease the effects of radiochemotherapy. Human recombinant vascular endothelial inhibitor (endostar) can improve the sensitivity to chemoradiation via selectively inhibiting the migration of endothelial cells and the formation of tumor vessels. Moreover, it would induce vascular remodeling and normalization of the tumor vasculature, which will effectively aid the delivery of oxygen and anticancer drugs. In sum, antiangiogenesis in combination with chemoradiotherapy will be a promising way of treatment for NPC. In this study, the first-treated patients with NPC (stage Ⅲ or Ⅳa) confirmed by pathology, and patients with recurrent and metastatic NPC will be randomly assigned to two groups (1:1): a trial group (DDP, 5-FU, endostar and sequential intensity modulated radiation therapy (IMRT)), and a control group (DDP，5-FU and sequential IMRT). Evaluations will be developed including progression-free survival (PFS), Overall response rate（ORR）, overall survival (OS), adverse effects rate and quality of life. This research will provide more evidences of evidence-based medicine for the safety and tolerability of endostar and the clinical application of endostar in NPC treatment.

Detailed Summary:
Sponsor: China Three Gorges University, Yichang, China

Current Primary Outcome:

  • Progression-free Survival [ Time Frame: Patients will be followed from the day in which patients are enrolled the clinical trial and end up one year later, during the one year the patients will be observed whether they have disease progress or die from any cause. ]
  • Overall response rate [ Time Frame: After the second periodicity chemotherapy, an expected average of 12 weeks, the rate of patients with complete response and partial response accounted for the total number of assessable cases . ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse effects as assessed by adverse events [ Time Frame: It is the time from the start of treatment to 20 weeks ]
  • Overall survival [ Time Frame: Patients will be followed from the day in which patients are enrolled the clinical trial and end up two years later, during the two years the patients will be observed whether they die from any cause. ]
  • Quality of Life measured by the ECDG score [ Time Frame: Firstly, Patients will be assessed before the start of periodicity treatment, then they will be assessed 20 weeks and 24 weeks after the treatment. ]


Original Secondary Outcome: Same as current

Information By: China Three Gorges University, Yichang, China

Dates:
Date Received: April 7, 2015
Date Started: June 2014
Date Completion: June 2017
Last Updated: May 14, 2015
Last Verified: March 2015