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

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.

Conditions

• Nasopharyngeal Carcinoma

Interventions

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

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

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

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

Sponsors & Collaborators

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• 303rd Hospital of the People's Liberation Army

  collaborator OTHER

• Nanning Second People's Hospital

  collaborator OTHER

• Guangxi Traditional Chinese Medical University

  collaborator OTHER

• Guilin Medical College

  collaborator OTHER

• Guangxi Naxishan Hospital

  collaborator OTHER

• Liuzhou Workers' Hospital

  collaborator OTHER_GOV

• LiuZhou People's Hospital

  collaborator OTHER

• Liuzhou Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Liuzhou Cancer Hospital

  collaborator UNKNOWN

• Liuzhou Railway hospital

  collaborator UNKNOWN

• First People's Hospital of Yulin

  collaborator OTHER

• The Red Cross hospital of YuLin

  collaborator UNKNOWN

• Guigang People's Hospital

  collaborator OTHER

• Wuzhou Red Cross Hospital

  collaborator OTHER

• Guangxi Medical University

  lead OTHER

Principal Investigators

• Wang R. sheng, M.D. · Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University

• Wang R sheng, M.D. · Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University

• Wu Fang, M.D. · Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2012-11-30

Completion

2017-12-31

Countries

• China

Study Locations