drugset / Trial / NCT02636231
Endostar for Locally Recurrent Nasopharyngeal Carcinoma
Phase 2
Unknown
96 enrolled
Sun Yat-sen University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University · collabFirst Affiliated Hospital of Gannan Medical University · collabFirst People's Hospital of Foshan · collabJiangXi Province Tumor Hospital · collabSecond Affiliated Hospital of Nanchang University · collabThe Affiliated Ganzhou Hospital of Nanchang University · collabThe First Affiliated Hospital of Clinical Medicine of G.D.P.U. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether endostar and IMRT is effective in the treatment of locally recurrent nasopharyngeal carcinoma patients compared with IMRT alone.
Timeline
- Start
- 2015-11
- Primary completion
- 2020-03
- Completion
- 2021-12
Publications
- Results Han F, Zhao C, Huang SM, Lu LX, Huang Y, Deng XW, Mai WY, Teh BS, Butler EB, Lu TX. Long-term outcomes and prognostic factors of re-irradiation for locally recurrent nasopharyngeal carcinoma using intensity-modulated radiotherapy. Clin Oncol (R Coll Radiol). 2012 Oct;24(8):569-76. doi: 10.1016/j.clon.2011.11.010. Epub 2011 Dec 29.
- Results Zhang K, Yang S, Zhu Y, Mo A, Zhang D, Liu L. Protection against acute radiation-induced lung injury: a novel role for the anti-angiogenic agent Endostar. Mol Med Rep. 2012 Aug;6(2):309-15. doi: 10.3892/mmr.2012.903. Epub 2012 May 4.
- Results Peng F, Xu Z, Wang J, Chen Y, Li Q, Zuo Y, Chen J, Hu X, Zhou Q, Wang Y, Ma H, Bao Y, Chen M. Recombinant human endostatin normalizes tumor vasculature and enhances radiation response in xenografted human nasopharyngeal carcinoma models. PLoS One. 2012;7(4):e34646. doi: 10.1371/journal.pone.0034646. Epub 2012 Apr 9.
- Results Tong RT, Boucher Y, Kozin SV, Winkler F, Hicklin DJ, Jain RK. Vascular normalization by vascular endothelial growth factor receptor 2 blockade induces a pressure gradient across the vasculature and improves drug penetration in tumors. Cancer Res. 2004 Jun 1;64(11):3731-6. doi: 10.1158/0008-5472.CAN-04-0074.
- Results Tian YM, Guan Y, Xiao WW, Zeng L, Liu S, Lu TX, Zhao C, Han F. Long-term survival and late complications in intensity-modulated radiotherapy of locally recurrent T1 to T2 nasopharyngeal carcinoma. Head Neck. 2016 Feb;38(2):225-31. doi: 10.1002/hed.23880. Epub 2015 May 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Endostatins | Protein / enzyme biologic | 201 mg | Intravenous |