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

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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

Trial contacts and locations

1

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Central trial contact

Jun Ma, M.D.

Data sourced from clinicaltrials.gov

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