A Multicenter Trial Comparing Multi-course Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
NCT ID: NCT00705627
Last Updated: 2014-05-28
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
400 participants
INTERVENTIONAL
2008-06-30
2017-06-30
Brief Summary
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In our study, in order to investigate the effect and adverse reaction of neoadjuvant chemotherapy plus CCRT on distance metastasis and locoregionally relapse, four hundred patients with high risk of distance metastasis will be randomly divided into two groups, comparing neoadjuvant chemotherapy (DDP+5FU) plus CCRT (DDP) and CCRT (DDP) alone. We aim to find out the best therapeutic regimen with lowest adverse reaction for NPCS with high risk of distance metastasis.
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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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B
Drug: cisplatin. Patients in the control arm received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.
neoadjuvant chemotherapy plus concurrent chemoradiotherapy
Drug: cisplatin,fluorouracil. Patients received cisplatin 80mg/m2 on day 1,fluorouracil 4000mg/m2 civ 120 hours every three weeks for two cycles, then received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.
Interventions
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neoadjuvant chemotherapy plus concurrent chemoradiotherapy
Drug: cisplatin,fluorouracil. Patients received cisplatin 80mg/m2 on day 1,fluorouracil 4000mg/m2 civ 120 hours every three weeks for two cycles, then received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Original clinical stage must be T4 or N2-3 （UICC 2002）
* Male and no pregnant female
* Age between 18-60
* WBC ≥4,000/mm3 and PLT ≥ 100,000/mm3
* With normal liver function test (ALT、AST≤2.5×ULN)
* With normal renal function test (Creatinine ≤ 1.5×ULN)
* Performance status scale ECOG grade 0，1
* Without radiotherapy or chemotherapy
* Patients must give signed informed consent
Exclusion Criteria
* The presence of uncontrolled life-threatening illness
* Receiving other ways of anti-cancer therapy
* Receiving radiotherapy or chemotherapy
* Investigator consider the patients can't finish the whole study
18 Years
60 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
OTHER
Affiliated Cancer Hospital of Shantou University Medical College
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Hong Ming-huang
the director of GCP
Principal Investigators
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Minghuang Hong, MD
Role: STUDY_CHAIR
Sun Yet sen Cancer Center, China
Locations
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Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2007047
Identifier Type: -
Identifier Source: org_study_id
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