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

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ClinicalTrials.gov Identifier: NCT01479504
Recruitment Status : Unknown
Verified October 2011 by Wang Rensheng, Guangxi Medical University.
Recruitment status was:  Recruiting
First Posted : November 24, 2011
Last Update Posted : November 28, 2011
Sponsor:
Collaborators:
People's Hospital of Guangxi
303rd Hospital of the People's Liberation Army
Nanning Second People's Hospital
Guangxi Traditional Chinese Medical University
Guilin Medical College
Guangxi Naxishan Hospital
Liuzhou Worker's Hospital
Liuzhou People's Hospital
Liuzhou Hospital of Traditional Chinese Medicine
Liuzhou Cancer Hospital
Liuzhou Railway hospital
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

Study Description
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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 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.


Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: nedaplatin and docetaxel Drug: cisplatin and docetaxel Phase 3

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2011
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : December 2017

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1A(nedaplatin and IMRT)
neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and Intensity-modulated Radiation Therapy(IMRT)
 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
Active Comparator: 1B(cisplatin and IMRT)
neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and Intensity-modulated Radiation Therapy(IMRT)
 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: 2A(nedaplatin and CRT)
neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and conventional fractionation radiotherapy(CRT)
 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
Active Comparator: 2B((cisplatin and CRT))
neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and conventional fractionation radiotherapy(CRT)
 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


Outcome Measures
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Primary Outcome Measures :
  1. complete response (CR) rate [ Time Frame: 3 months ]
    3 months after treatment


Secondary Outcome Measures :
  1. Acute toxicities [ Time Frame: 2 years ]
    Acute toxicity will be measured by CTCAE3.0

  2. Overall Survival [ Time Frame: 1,3,5 years ]
    1 years，3 years and 5 years overall survival,disease free survival,distant metastases free survival

  3. cost-effectiveness ratio [ Time Frame: 3 months ]
    Calculate the cost(C) and complete response rate(E) of each group 3 months after treatment,then calculate cost-effectiveness ratio(C/E).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479504


Contacts
Contact: Wang R Sheng, M.D. 86(0771)3276223 wrsgx@yahoo.com.cn
Contact: Wu Fang, M.D. 86(0771)3276313 96160f@163.com

Locations
China, Guangxi
Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University Recruiting
Nanning, Guangxi, China, 530021
Contact: Wang R Sheng, M.D.    8613807806008    wrsgx@yahoo.com.cn   
Contact: Wu Fang, M.D.    8613978880156    96160f@163.com   
Principal Investigator: Wang R Sheng, M.D.         
Principal Investigator: Wu Fang, M.D.         
Sponsors and Collaborators
Guangxi Medical University
People's Hospital of Guangxi
303rd Hospital of the People's Liberation Army
Nanning Second People's Hospital
Guangxi Traditional Chinese Medical University
Guilin Medical College
Guangxi Naxishan Hospital
Liuzhou Worker's Hospital
Liuzhou People's Hospital
Liuzhou Hospital of Traditional Chinese Medicine
Liuzhou Cancer Hospital
Liuzhou Railway hospital
First People's Hospital of Yulin
The Red Cross hospital of YuLin
Guigang People's Hospital
The Red Cross hospital of Wuzhou
Investigators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Wang Rensheng, Director, Guangxi Medical University
ClinicalTrials.gov Identifier: NCT01479504     History of Changes
Other Study ID Numbers: GuangxiMU
First Posted: November 24, 2011    Key Record Dates
Last Update Posted: November 28, 2011
Last Verified: October 2011

Keywords provided by Wang Rensheng, Guangxi Medical University:
Nasopharyngeal Carcinoma
neoadjuvant chemotherapy
concurrent chemoradiotherapy
Nedaplatin

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
 Stomatognathic Diseases
Otorhinolaryngologic Diseases
Docetaxel
Nedaplatin
Cisplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action