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

Send

Updated on 19 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 Identifier	NCT04437329
Sponsor	Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

induction chemotherapy

nasopharyngeal carcinoma

chemoradiotherapy

karnofsky performance status

concurrent radiochemotherapy

cisplatin

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma