A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

This study is currently recruiting participants.
Verified October 2011 by Guangxi Medical University
Sponsor:
Collaborators:
The People's Hospital of Guangxi Zhuang Autonomous Region
303rd Hospital of the People's Liberation Army
The Second People's Hospital of Nanning
Guangxi Traditional Chinese Medical University
Guilin Medical College
Guangxi Naxishan Hospital
Liuzhou Worker's Hospital
Liuzhou People's Hospital
The Hospital of traditional Chinese medicine of Liuzhou
Liuzhou Cancer Hospital
Liuzhou Railway hospital
The First People's Hospital of YuLin
The Red Cross hospital of YuLin
Guigang People's Hospital
The Red Cross hospital of Wuzhou
Information provided by (Responsible Party):
Wang Rensheng, Guangxi Medical University
ClinicalTrials.gov Identifier:
NCT01479504
First received: November 16, 2011
Last updated: November 24, 2011
Last verified: October 2011

November 16, 2011
November 24, 2011
November 2011
November 2012   (final data collection date for primary outcome measure)
complete response (CR) rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
3 months after treatment
Same as current
Complete list of historical versions of study NCT01479504 on ClinicalTrials.gov Archive Site
  • Acute toxicities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Acute toxicity will be measured by CTCAE3.0
  • Overall Survival [ Time Frame: 1,3,5 years ] [ Designated as safety issue: No ]
    1 years,3 years and 5 years overall survival,disease free survival,distant metastases free survival
  • cost-effectiveness ratio [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Calculate the cost(C) and complete response rate(E) of each group 3 months after treatment,then calculate cost-effectiveness ratio(C/E).
Same as current
Not Provided
Not Provided
 
A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
A Multicenter Trial Evaluating the Efficacy and Safety of Nedaplatin Plus Docetaxel in Neoadjuvant Chemotherapy Followed by Nedaplatin in Concurrent Chemoradiation for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

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 nedaplatin in concurrent chemoradiotherapy, compared to cisplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by cisplatin in concurrent chemoradiotherapy for patients with locoregionally advanced nasopharyngeal carcinoma.

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.

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 radiotherapy(CRT)group. Then the patients in IMRT group/CRT group are randomly assigned to receive nedaplatin+docetaxel in neoadjuvant chemotherapy plus nedaplatin alone in concurrent chemoradiotherapy or cisplatin+docetaxel in neoadjuvant chemotherapy plus cisplatin alone in concurrent chemoradiotherapy.Evaluate the overall survival, the distant metastases free survival, and disease free survival of the patients treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Nasopharyngeal Carcinoma
  • Drug: 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

    Other Name: TN
  • Drug: 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 Name: TP
  • Experimental: 1A(nedaplatin and IMRT)
    neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and Intensity-modulated Radiation Therapy(IMRT)
    Intervention: Drug: nedaplatin and docetaxel
  • Active Comparator: 1B(cisplatin and IMRT)
    neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and Intensity-modulated Radiation Therapy(IMRT)
    Intervention: Drug: cisplatin and docetaxel
  • Experimental: 2A(nedaplatin and CRT)
    neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and conventional fractionation radiotherapy(CRT)
    Intervention: Drug: nedaplatin and docetaxel
  • Active Comparator: 2B((cisplatin and CRT))
    neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and conventional fractionation radiotherapy(CRT)
    Intervention: Drug: cisplatin and docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2
December 2017
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
18 Years to 70 Years
No
Contact: Wang R Sheng, M.D. 86(0771)3276223 wrsgx@yahoo.com.cn
Contact: Wu Fang, M.D. 86(0771)3276313 96160f@163.com
China
 
NCT01479504
GuangxiMU
Yes
Wang Rensheng, Guangxi Medical University
Guangxi Medical University
  • The People's Hospital of Guangxi Zhuang Autonomous Region
  • 303rd Hospital of the People's Liberation Army
  • The Second People's Hospital of Nanning
  • Guangxi Traditional Chinese Medical University
  • Guilin Medical College
  • Guangxi Naxishan Hospital
  • Liuzhou Worker's Hospital
  • Liuzhou People's Hospital
  • The Hospital of traditional Chinese medicine of Liuzhou
  • Liuzhou Cancer Hospital
  • Liuzhou Railway hospital
  • The First People's Hospital of YuLin
  • The Red Cross hospital of YuLin
  • Guigang People's Hospital
  • The Red Cross hospital of Wuzhou
Study Chair: Wang R. sheng, M.D. Department of Radiotherapy,the First Affiliated Hospital of Guangxi Medical University
Principal Investigator: Wang R sheng, M.D. Department of Radiotherapy,the First Affiliated Hospital of Guangxi Medical University
Principal Investigator: Wu Fang, M.D. Department of Radiotherapy,the First Affiliated Hospital of Guangxi Medical University
Guangxi Medical University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP