Trials / Completed
CompletedNCT02444949
A Trial of Endostar in Combination With Chemotherapy of DF and Sequential Intensity Modulated Radiation Therapy for Patients With Advanced Nasopharyngeal Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- China Three Gorges University, Yichang, China · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | endostar | |
| RADIATION | intensity modulated radiation | |
| DRUG | cisplatin |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2016-12-01
- Completion
- 2019-12-01
- First posted
- 2015-05-15
- Last updated
- 2020-06-24
Source: ClinicalTrials.gov record NCT02444949. Inclusion in this directory is not an endorsement.