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

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01479504
• Other study ID #: GuangxiMU
• Status: Recruiting
• Phase: Phase 3
• First received: November 16, 2011
• Last updated: November 24, 2011
• Start date: November 2011
• Est. completion date: December 2017

Study information

• Verified date: October 2011
• Source: Guangxi Medical University
• Contact: Wang R Sheng, M.D.
• Phone: 86(0771)3276223
• Email: wrsgx[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: December 2017
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
China	Department of Radiotherapy,the First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (16)

Lead Sponsor

Collaborator

Guangxi Medical University

303rd Hospital of the People's Liberation Army, First People's Hospital of Yulin, Guangxi Naxishan Hospital, Guangxi Traditional Chinese Medical University, Guigang People's Hospital, Guilin Medical College, Liuzhou Cancer Hospital, Liuzhou Hospital of Traditional Chinese Medicine, Liuzhou People's Hospital, Liuzhou Railway hospital, Liuzhou Worker's Hospital, Nanning Second People's Hospital, People's Hospital of Guangxi, The Red Cross hospital of Wuzhou, The Red Cross hospital of YuLin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete response (CR) rate	3 months after treatment	3 months	No
Secondary	Acute toxicities	Acute toxicity will be measured by CTCAE3.0	2 years	Yes
Secondary	Overall Survival	1 years,3 years and 5 years overall survival,disease free survival,distant metastases free survival	1,3,5 years	No
Secondary	cost-effectiveness ratio	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	No