Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| JiangXi Province Tumor Hospital | UNKNOWN |
| The First Affiliated Hospital of Clinical Medicine of G.D.P.U. | UNKNOWN |
| Second Affiliated Hospital of Nanchang University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Locally recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but severe late toxicities become the most common reason of death in IMRT salvaged NPC patients.
The aim of this phase II randomized controlled study is to address the efficacy of concurrent Endostar (Endostatins) with IMRT to reduce the occurrence of severe late toxicities compared with IMRT alone for locally recurrent NPC patients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMRT and concurrent Endostar | Active Comparator | IMRT and concurrent Endostar (Endostatins) to treat locally recurrent NPC patients; Endostar is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles. IMRT is to give GTV 60Gy in 27 fractions. |
|
| IMRT alone | Experimental | IMRT alone to treat locally recurrent NPC patients. IMRT is to give GTV 60Gy in 27 fractions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endostatins | Drug | Endostar (Endostatins) is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema | From 3 months after the end of IMRT to 1 year after the end of IMRT |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with severe acute toxicities as assessed by CTCAE v3.0 | From the beginning of IMRT to 3 months after the end of IMRT | |
| Overall survival | From the beginning the IMRT to 3 year after the end of IMRT |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fei Han, M.D., Ph.D. | China: Ethics Committee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First People's Hospital of Foshan | Foshan | Guangdong | 528000 | China | ||
| Cancer Center of Guangzhou Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22209574 | Result | 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. | |
| 22562140 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D043169 | Endostatins |
| C522911 | endostar protein |
| ID | Term |
|---|---|
| D043165 | Angiostatic Proteins |
| D042501 | Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
Not provided
Not provided
| First People's Hospital of Foshan |
| OTHER |
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | OTHER |
| The Affiliated Ganzhou Hospital of Nanchang University | OTHER |
| First Affiliated Hospital of Gannan Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| IMRT | Radiation | IMRT is to give GTV 60Gy in 27 fractions. |
|
| Guangzhou |
| Guangdong |
| 510000 |
| China |
| The First Affiliated Hospital of Clinical Medicine of G.D.P.U. | Guangzhou | Guangdong | 510000 | China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| The Affiliated GanZhou Hospital of NanChang University | Ganzhou | Jiangxi | 341000 | China |
| The First Hospital of Gannan Medical University | Ganzhou | Jiangxi | 341000 | China |
| Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| JiangXi Province Tumor Hospital | Nanchang | Jiangxi | 330029 | China |
| 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. |
| 22496834 | Result | 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. |
| 15172975 | Result | 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. |
| 25244494 | Result | 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. |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D043170 | Collagen Type XVIII |
| D024041 | Non-Fibrillar Collagens |
| D003094 | Collagen |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D001685 | Biological Factors |