Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in IC + CCRT for Locoregionally Advanced NPC

Summary

This is a phase 3, multicentre, non-inferiority, randomised factorial trial. The purpose of this study is to study the efficacy and safety of nedaplatin versus cisplatin, and capecitabine versus fluorouracil in induction docetaxel, cisplatin, and fluorouracil (TPF) plus concurrent chemoradiotherapy with cisplatin (P-RT) in locoregionally advanced nasopharyngeal carcinoma (NPC).

Conditions

• Nasopharyngeal Carcinoma

Interventions

DRUG

docetaxel, nedaplatin, and capecitabine

Patients receive docetaxel(60 mg/m2 on day 1), nedaplatin (60 mg/m2 on day 1) and capecitabine (625 mg/m2 bid, on Days 1 to 14) every three weeks for three cycles before the radiotherapy.

DRUG

nedaplatin

Patients receive concurrent nedaplatin (100mg/m2) every three weeks for two cycles during radiotherapy.

DRUG

docetaxel, cisplatin, and fluorouracil

Patients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.

DRUG

cisplatin

Patients receive concurrent cisplatin (100mg/m2) every three weeks for two cycles during radiotherapy.

DRUG

docetaxel, cisplatin, and capecitabine

Patients receive docetaxel(60 mg/m2 on day 1), cisplatin (60 mg/m2 on day 1) and capecitabine (625 mg/m2 bid, on Days 1 to 14) every three weeks for three cycles before the radiotherapy.

DRUG

docetaxel, nedaplatin, and fluorouracil

Patients receive docetaxel (60mg/m2 on day 1), nedaplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.

Sponsors & Collaborators

• Tongji Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Peking University

  collaborator OTHER

• Air Force Military Medical University, China

  collaborator OTHER

• Second Affiliated Hospital of Soochow University

  collaborator OTHER

• The First Affiliated Hospital of Guangdong Pharmaceutical University

  collaborator OTHER

• First People's Hospital of Foshan

  collaborator OTHER

• Fifth Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Cancer Hospital of Guizhou Province

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Jilin Provincial Tumor Hospital

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Hunan Cancer Hospital

  collaborator OTHER

• Cancer Hospital of Guangxi Medical University

  collaborator OTHER

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Sun Yat-sen University

  lead OTHER

Principal Investigators

• Principal Investigator Principal Investigator, M.D. · Sun Yat-sen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-30

Primary Completion

2024-06-30

Completion

2026-06-30

Countries

• China

Study Locations