Status:
UNKNOWN
A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Lead Sponsor:
Guangxi Medical University
Collaborating Sponsors:
People's Hospital of Guangxi Zhuang Autonomous Region
303rd Hospital of the People's Liberation Army
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This study is a multicenter trial.The primary objective is to estimate short-term efficacy and acute toxicities of nedaplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by ne...
Detailed Description
Patients with clinical stage T3-4N1/N2-3 (UICC 7th edition)are divided into two groups according to informed consent:intensity-modulated radiation therapy（IMRT）group and conventional fractionation rad...
Eligibility Criteria
Inclusion
- histologically proven nasopharyngeal carcinoma for primary treatment with radical intent
- 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
- primary treatment with palliative intent
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01479504
Start Date
November 1 2011
End Date
December 1 2017
Last Update
November 28 2011
Active Locations (1)
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1
Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021