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

November 24, 2011 updated by: Wang Rensheng, Guangxi Medical University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

2

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Wu Fang, M.D.
  • Phone Number: 86(0771)3276313
  • Email: 96160f@163.com

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wang R Sheng, M.D.
        • Principal Investigator:
          • Wu Fang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • TP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete response (CR) rate
Time Frame: 3 months
3 months after treatment
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute toxicities
Time Frame: 2 years
Acute toxicity will be measured by CTCAE3.0
2 years
Overall Survival
Time Frame: 1,3,5 years
1 years，3 years and 5 years overall survival,disease free survival,distant metastases free survival
1,3,5 years
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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangxi Medical University

Collaborators

Liuzhou Workers Hospital
Wuzhou Red Cross Hospital
Guilin Medical College
People's Hospital of Guangxi
303rd Hospital of the People's Liberation Army
Nanning Second People's Hospital
Guangxi Traditional Chinese Medical University
Guangxi Naxishan 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

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 16, 2011

First Submitted That Met QC Criteria

November 22, 2011

First Posted (Estimate)

November 24, 2011

Study Record Updates

Last Update Posted (Estimate)

November 28, 2011

Last Update Submitted That Met QC Criteria

November 24, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GuangxiMU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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