Status:
RECRUITING
Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma
Lead Sponsor:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- WBC≥4×10\^9/ l, platelet ≥ 100×10\^9/ l and hemoglobin ≥ 90g/l
- With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln)
- With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min)
- Satisfactory performance status: KARNOFSKY scale (KPS) \> 70
- Patients must give signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT04437329
Start Date
August 1 2020
End Date
June 30 2029
Last Update
May 10 2022
Active Locations (1)
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1
Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, China, 510095