Clinical trial NCT04437329: Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma
Official title: Nedaplatin Versus Cisplatin in Induction Chemotherapy Combined With Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma：a Prospective, Parallel, Randomized, Open Labeled, Phase III Non-Inferiority Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: induction chemotherapy
nedaplatin
cisplatin
concurrent chemoradiotherapy
Lead sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

Eligibility criteria: Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
2. Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system
3. No evidence of distant metastasis (M0)
4. Age between 18-65
5. WBC≥4×10\^9/ l, platelet ≥ 100×10\^9/ l and hemoglobin ≥ 90g/l
6. With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln)
7. With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min)
8. Satisfactory performance status: KARNOFSKY scale (KPS) \> 70
9. Patients must give signed informed consent

Exclusion Criteria:

1. Histologically confirmed keratinizing nasopharyngeal carcinoma (WHO I)
2. Age \>65 or \< 18 years
3. Treatment with palliative intent
4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
5. History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes
6. History of previous radiotherapy
7. Pregnancy or lactation
8. 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

Primary outcomes:
measure: Progress-Free Survival (PFS)
timeFrame: 3 years
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: 3 years
measure: Locoregional Relapse-Free Survival(LRRFS)
timeFrame: 3 years
measure: Distant metastasis-Free Survival(DMFS)
timeFrame: 3 years
measure: Quality of life (QoL)
timeFrame: 3 years
measure: Objective Response Rate (ORR)
timeFrame: 12 weeks after the interventions
measure: Disease Control Rate (DCR)
timeFrame: 12 weeks after the interventions
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Jinquan Liu, M.D
role: STUDY_DIRECTOR
References: