Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in IC + CCRT for Locoregionally Advanced NPC (NX-NPC)

Sun Yat-sen University

Status and phase: Not yet enrolling; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: docetaxel, cisplatin, and fluorouracil; Drug: docetaxel, cisplatin, and capecitabine; Drug: cisplatin; Drug: docetaxel, nedaplatin, and capecitabine; Drug: docetaxel, nedaplatin, and fluorouracil; Drug: nedaplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03503136

2018-FXY-076

Details and patient eligibility

About

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).

Full description

In this study, patients with non-keratinizing NPC and staged III-IVA (except T3-4N0) are randomly assigned to one of the four groups: Group A: TPF+P-RT; Group B: TNF+N-RT; Group C: TPX+P-RT; Group D: TNX+N-RT. In induction chemotherapy, patients will receive docetaxel(60 mg/m2 on day 1), cisplatin or nedaplatin (60 mg/m2 on day 1) and fluorouracil (600 mg/m2 on Days 1 to 5) or capecitabine (625 mg/m2 bid, on Days 1 to 14) every three weeks for three cycles before the radical radiotherapy. Concurrent cisplatin or nedaplatin (100mg/m2 on day 1) was given every three weeks for two cycles during radiotherapy. Patients are stratified according to the treatment centers and stage. The primary endpoint is progression-free survival (PFS). Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), toxic effects, and quality of life (QOL). All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Enrollment: 632 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

632 participants in 4 patient groups

A (TPF+P-RT)

Experimental group

Description:

Induction docetaxel, cisplatin, and fluorouracil plus concurrent chemoradiotherapy with cisplatin

Treatment:

Drug: cisplatin

Drug: docetaxel, cisplatin, and fluorouracil

B (TNF+N-RT)

Experimental group

Description:

Induction docetaxel, nedaplatin, and fluorouracil plus concurrent chemoradiotherapy with nedaplatin

Treatment:

Drug: docetaxel, nedaplatin, and fluorouracil

Drug: nedaplatin

C (TPX+P-RT)

Experimental group

Description:

Induction docetaxel, cisplatin, and capecitabine plus concurrent chemoradiotherapy with cisplatin

Treatment:

Drug: cisplatin

Drug: docetaxel, cisplatin, and capecitabine

D (TNX+N-RT)

Experimental group

Description:

Induction docetaxel, nedaplatin, and capecitabine plus concurrent chemoradiotherapy with nedaplatin

Treatment:

Drug: nedaplatin

Drug: docetaxel, nedaplatin, and capecitabine