Endostar for Locally Recurrent Nasopharyngeal Carcinoma
NCT ID: NCT02636231
Last Updated: 2021-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
96 participants
INTERVENTIONAL
2015-11-30
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IMRT and concurrent Endostar
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.
Endostatins
Endostar (Endostatins) is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles.
IMRT
IMRT is to give GTV 60Gy in 27 fractions.
IMRT alone
IMRT alone to treat locally recurrent NPC patients. IMRT is to give GTV 60Gy in 27 fractions.
IMRT
IMRT is to give GTV 60Gy in 27 fractions.
Interventions
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Endostatins
Endostar (Endostatins) is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles.
IMRT
IMRT is to give GTV 60Gy in 27 fractions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. No evidence of distant metastasis
3. More than 1 year from the end of the first course of radiotherapy
4. Male, or female not in the phase of lactating or pregnancy
5. ECOG 0-2
6. Aged 18-70 years old
7. WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L
8. Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits
9. Written informed consort signed
Exclusion Criteria
2. Evidence of distant metastasis
3. Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
4. Severe, active co-morbidity
5. Prior anti-tumor treatment after diagnosis of local recurrence
6. MRI was not performed 3 months after the first course of radiotherapy
7. Abnormal function of heart, brain and lungs, etc
8. Lactation or pregnancy
9. Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence
18 Years
70 Years
ALL
No
Sponsors
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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
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
Sun Yat-sen University
OTHER
Responsible Party
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Fei Han
Associate Professor
Principal Investigators
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Fei Han, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
China: Ethics Committee
Locations
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First People's Hospital of Foshan
Foshan, Guangdong, China
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Clinical Medicine of G.D.P.U.
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The Affiliated GanZhou Hospital of NanChang University
Ganzhou, Jiangxi, China
The First Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
JiangXi Province Tumor Hospital
Nanchang, Jiangxi, China
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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NPC201501
Identifier Type: -
Identifier Source: org_study_id
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