Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma
NCT ID: NCT02111460
Last Updated: 2020-05-08
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
PHASE3
126 participants
INTERVENTIONAL
2013-10-31
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiotherapy
Systemic Chemotherapy Combined with Loco-regional Radiotherapy
Loco-regional Radiotherapy
with or without Loco-regional Radiotherapy
Chemotherapy
Chemotherapy alone without Loco-regional Radiotherapy
Loco-regional Radiotherapy
with or without Loco-regional Radiotherapy
Interventions
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Loco-regional Radiotherapy
with or without Loco-regional Radiotherapy
Eligibility Criteria
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Inclusion Criteria
* Histologic diagnosis of nasopharyngeal carcinoma
* T1-4N0-3M1,IVC(according to the 7th AJCC edition)
* Aged between 18 and 65 years
* KPS≥70
* The therapeutic effect evaluation is CR or PR accomplished three course of cisplatin and 5-Fu
* Voluntary to participate and sign informed consent document
Exclusion Criteria
* Clinically significant cardiac, heart function less than or equal to 3 level
* Clinically significant respiratory disease,lung function less than or equal to 3 level
* Blood routine examination: WBC\<3×109/L, Hemoglobin\<90g/L, platelet count\<75×109/L
* Abnormal liver function: total bilirubin or ALT or AST\>2×ULN
* Abnormal renal function:serum creatinine\>1.5×ULN
* Pregnant or lactating women
* The therapeutic effect evaluation is SD or PD accomplished three course of cisplatin and 5-Fu
18 Years
65 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Guangdong Provincial People's Hospital
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Ming-Yuan Chen
professor & chief physician
Principal Investigators
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Ming y Chen, MD,Phd
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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References
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You R, Liu YP, Huang PY, Zou X, Sun R, He YX, Wu YS, Shen GP, Zhang HD, Duan CY, Tan SH, Cao JY, Li JB, Xie YL, Zhang YN, Wang ZQ, Yang Q, Lin M, Jiang R, Zhang MX, Hua YJ, Tang LQ, Zhuang AH, Chen QY, Guo L, Mo HY, Chen Y, Mai HQ, Ling L, Liu Q, Chua MLK, Chen MY. Efficacy and Safety of Locoregional Radiotherapy With Chemotherapy vs Chemotherapy Alone in De Novo Metastatic Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1345-1352. doi: 10.1001/jamaoncol.2020.1808.
Other Identifiers
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SYSUCC5010
Identifier Type: -
Identifier Source: org_study_id
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