A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
NCT ID: NCT01479504
Last Updated: 2011-11-28
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
2 participants
INTERVENTIONAL
2011-11-30
2017-12-31
Brief Summary
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Secondary objectives are to evaluate the overall survival, the distant metastases free survival, and disease free survival of patients with locoregionally advanced nasopharyngeal carcinoma treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1A(nedaplatin and IMRT)
neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and Intensity-modulated Radiation Therapy(IMRT)
nedaplatin and docetaxel
neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy
concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy
1B(cisplatin and IMRT)
neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and Intensity-modulated Radiation Therapy(IMRT)
cisplatin and docetaxel
neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy
concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy
2A(nedaplatin and CRT)
neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and conventional fractionation radiotherapy(CRT)
nedaplatin and docetaxel
neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy
concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy
2B((cisplatin and CRT))
neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and conventional fractionation radiotherapy(CRT)
cisplatin and docetaxel
neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy
concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy
Interventions
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nedaplatin and docetaxel
neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy
concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy
cisplatin and docetaxel
neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy
concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy
nedaplatin and docetaxel
neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy
concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy
cisplatin and docetaxel
neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy
concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* non-keratinizing or undifferentiated type
* clinical stage III-IVb (UICC 7th edition)
* age between 18-70
* satisfactory performance status: Karnofsky scale (KPS) \> 70.
* hemoglobin \> 100g/L, WBC \> 4.0x10\*9/L, Plt \> 100x10\*9/L
* serum creatinine level \< 1.6 mg/dL or creatinine clearance ≥ 60 mL/min.
* normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤1.5ULN
* patients must be informed of the investigational nature of this study and give written informed consent.
* anticipated life span more than 6 month
Exclusion Criteria
* WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma Evidence of distant metastases
* pregnancy or lactation
* history of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
* prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
* prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years
* any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
18 Years
70 Years
ALL
No
Sponsors
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People's Hospital of Guangxi Zhuang Autonomous Region
OTHER
303rd Hospital of the People's Liberation Army
OTHER
Nanning Second People's Hospital
OTHER
Guangxi Traditional Chinese Medical University
OTHER
Guilin Medical College
OTHER
Guangxi Naxishan Hospital
OTHER
Liuzhou Workers' Hospital
OTHER_GOV
LiuZhou People's Hospital
OTHER
Liuzhou Hospital of Traditional Chinese Medicine
OTHER
Liuzhou Cancer Hospital
UNKNOWN
Liuzhou Railway hospital
UNKNOWN
First People's Hospital of Yulin
OTHER
The Red Cross hospital of YuLin
UNKNOWN
Guigang People's Hospital
OTHER
Wuzhou Red Cross Hospital
OTHER
Guangxi Medical University
OTHER
Responsible Party
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Wang Rensheng
Director
Principal Investigators
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Wang R. sheng, M.D.
Role: STUDY_CHAIR
Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University
Wang R sheng, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University
Wu Fang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University
Locations
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Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Countries
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Central Contacts
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Facility Contacts
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Wang R Sheng, M.D.
Role: primary
Wu Fang, M.D.
Role: backup
Other Identifiers
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GuangxiMU
Identifier Type: -
Identifier Source: org_study_id