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

This study is currently recruiting participants. (see Contacts and Locations)

Verified October 2011 by Guangxi Medical University

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

ClinicalTrials.gov Identifier:

NCT01479504

First received: November 16, 2011

Last updated: November 24, 2011

Last verified: October 2011

History of Changes

Purpose

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	Intervention	Phase
Nasopharyngeal Carcinoma	Drug: nedaplatin and docetaxel Drug: cisplatin and docetaxel	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Cisplatin Docetaxel

Genetic and Rare Diseases Information Center resources: Nasopharyngeal Carcinoma

U.S. FDA Resources

Further study details as provided by Guangxi Medical University:

Primary Outcome Measures:

complete response (CR) rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
3 months after treatment

Secondary Outcome Measures:

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).


Estimated Enrollment:	2
Study Start Date:	November 2011
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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