NCT02237924

Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma

Effect of Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Locoregionally Advanced,Low-risk Nasopharyngeal Carcinoma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: First Affiliated Hospital of Guangxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

A total of 120 patients with pathologically confirmed locally advanced low-risk nasopharyngeal carcinoma were enrolled. They were randomly divided into two groups, with 60 patients in each group. One group was treated with intensity-modulated radiation therapy (IMRT) combined with Endostar and the other group was treated with IMRT combined with concurrent chemotherapy. The short term efficacy and the toxic and side effects of these treatments were evaluated. The 1-year, 3-year, 5-year overall survival and progression-free survival of patients were analyzed. Our data may provide an alternative option for the treatment of locally advanced low-risk nasopharyngeal carcinoma with high efficacy and low toxicity.

Detailed description

This study was a multicenter, open-label, randomized controlled clinical trial. A set of unified standards were used, including the clinical research program, inclusion criteria, exclusion criteria, chemoradiotherapy regimen and evaluation criteria. Nine medical centers participated in this study and 120 patients with pathologically confirmed locally advanced low-risk nasopharyngeal carcinoma were enrolled. These patients were stratified according to clinical stage and participating center, and were randomly divided into two groups: IMRT combined with Endostar group ( IMRT 70-74Gy, Endostar 7.5mg / m2, 2 cycles of continuous intravenous pumping, and 2 cycles of maintenance therapy after radiotherapy) and IMRT combined with concurrent chemotherapy group ( IMRT 70-74Gy, DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles). After treatment, follow-up was performed every 3 months. The treatment toxicity, local control rate, distant metastasis-free survival, overall survival, progression-free survival were observed and assessed.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	endostar	Endostar 7.5mg / m2, 2 cycles of continuous intravenous pumping for ten days,and 2 cycles of maintenance therapy after radiotherapy
DRUG	DDP	DDP:100mg/m2 for 2-3 cycles
RADIATION	IMRT	IMRT:70-74Gy for 2-3 cycles

Timeline

• Start date: 2014-09-01
• Primary completion: 2021-09-01
• Completion: 2022-01-01
• First posted: 2014-09-12
• Last updated: 2022-02-14

Locations

1 site across 1 country: China