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

Phase 3

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: nedaplatin and docetaxel; Drug: cisplatin and docetaxel

• Registration Number: NCT01479504
• Lead Sponsor: Guangxi Medical University

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.

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 Timeline

• Status Verified: 2011-10
• Study Start: 2011-11
• Study First Submitted: 2011-11-16
• Study First Submitted QC: 2011-11-22
• Study First Posted: 2011-11-24
• Last Update Submitted: 2011-11-24
• Last Update Posted: 2011-11-28
• Primary Completion: 2012-11
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1A(nedaplatin and IMRT)	nedaplatin and docetaxel	neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and Intensity-modulated Radiation Therapy(IMRT)
2A(nedaplatin and CRT)	nedaplatin and docetaxel	neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and conventional fractionation radiotherapy(CRT)
2B((cisplatin and CRT))	cisplatin and docetaxel	neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and conventional fractionation radiotherapy(CRT)
1B(cisplatin and IMRT)	cisplatin and docetaxel	neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and Intensity-modulated Radiation Therapy(IMRT)

Primary Outcome Measures

Name	Time	Method
complete response (CR) rate	3 months	3 months after treatment

Secondary Outcome Measures

Name	Time	Method
Acute toxicities	2 years	Acute toxicity will be measured by CTCAE3.0
Overall Survival	1,3,5 years	1 years，3 years and 5 years overall survival,disease free survival,distant metastases free survival
cost-effectiveness ratio	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).

Trial Locations

Locations (1)

Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China