Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma

  • STATUS
    Recruiting
  • End date
    Jun 30, 2029
  • participants needed
    352
  • sponsor
    Affiliated Cancer Hospital & Institute of Guangzhou Medical University
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Updated on 16 February 2024
See if I qualify
cancer
liver function tests
metastasis
docetaxel
induction chemotherapy
nasopharyngeal carcinoma
chemoradiotherapy
karnofsky performance status
carcinoma
fluorouracil
renal function test
nedaplatin
concurrent radiochemotherapy
cisplatin

Summary

To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.

Description

This is a prospective, parallel, randomized, open labeled, phase III, non-inferiority clinical trial to compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma patients in endemic area - nedaplatin, docetaxel and fluorouracil as induction chemotherapy regimen combined with nedaplatin as concurrent chemoradiotherapy (DNF-N) versus cisplatin, docetaxel and fluorouracil as induction chemotherapy regimen combined with cisplatin as concurrent chemoradiotherapy (DPF-P). All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is progress free survival (PFS).

Details
Condition Carcinoma, vulvar dysplasia and carcinoma, Nasopharyngeal Cancer, Nasopharyngeal Cancer, vulvar dysplasia and carcinoma
Age 18years - 65years
Treatment Cisplatin, Docetaxel, nedaplatin, fluorouracil, Docetaxel, cisplatin, fluorouracil, Nedaplatin, Intensity modulated-radiotherapy
Clinical Study IdentifierNCT04437329
SponsorAffiliated Cancer Hospital & Institute of Guangzhou Medical University
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system
No evidence of distant metastasis (M0)
Age between 18-65
WBC410^9/ l, platelet 10010^9/ l and hemoglobin 90g/l
With normal liver function test (TBILALTAST 2.5uln)
With normal renal function test (creatinine 1.5uln or ccr 60ml/min)
Satisfactory performance status: KARNOFSKY scale (KPS) > 70
Patients must give signed informed consent

Exclusion Criteria

Histologically confirmed keratinizing nasopharyngeal carcinoma (WHO I)
Age >65 or < 18 years
Treatment with palliative intent
Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes
History of previous radiotherapy
Pregnancy or lactation
Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, active hepatitis, and mental disturbance
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cancer
liver function tests
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chemoradiotherapy
karnofsky performance status
carcinoma
fluorouracil
renal function test
nedaplatin
concurrent radiochemotherapy
cisplatin

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