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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01479504

Enrollment

Registered

2011-11-24

Start date

2011-11-30

Completion date

2017-12-31

Last updated

2011-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma, neoadjuvant chemotherapy, concurrent chemoradiotherapy, Nedaplatin

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.

Interventions

DRUGnedaplatin 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

DRUGcisplatin 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
complete response (CR) rate	3 months	3 months after treatment

Secondary

Measure	Time frame	Description
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).

Countries

China

Contacts

Primary ContactWang R Sheng, M.D.

wrsgx@yahoo.com.cn86(0771)3276223

Backup ContactWu Fang, M.D.

96160f@163.com86(0771)3276313

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026