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

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Affiliated Cancer Hospital & Institute of Guangzhou Medical University; Air Force Military Medical University, China; Cancer Hospital of Guangxi Medical University; Cancer Hospital of Guizhou Province; Fifth Affiliated Hospital, Sun Yat-Sen University; First People's Hospital of Foshan; Fourth Military Medical University; Henan Cancer Hospital; Hunan Cancer Hospital; Jilin Provincial Tumor Hospital; Peking University; Second Affiliated Hospital of Soochow University; The First Affiliated Hospital of Guangdong Pharmaceutical University; Tongji Hospital; Wuhan Union Hospital, China; Xiangya Hospital of Central South University; Zhejiang Cancer Hospital
• Treatments: Capecitabine; Cisplatin; Docetaxel; Fluorouracil; Nedaplatin

Criteria

Inclusion Criteria:

• Age 18-60

• Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type)

• Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0 or 1

• Tumor staged as American Joint Committee on Cance (AJCC) III-IVA (except T3-4N0)

• Adequate marrow: leucocyte count ≥ 4×10^9/L, hemoglobin ≥ 90g/L and platelet count ≥ 100×10^9/L.

• Normal liver and renal 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 ≤ ULN; creatinine clearance ≥ 60 ml/min.

• Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

• WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.

• Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.

• Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).

• History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).

• Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.

• 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.

• Patients who could not tolerate or allergic to capecitabine.

• Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus.