Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Status and phase: Enrolling; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Radiation: Intensity modulated-radiotherapy; Drug: Cisplatin; Drug: Nedaplatin; Drug: Docetaxel, nedaplatin, fluorouracil; Drug: Docetaxel, cisplatin, fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT04437329

NPC-NDP

Details and patient eligibility

About

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

Full 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).

Enrollment: 352 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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352 participants in 2 patient groups

DNF-N

Experimental group

Description:

1. Induction chemotherapy: three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous nedaplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks 2. Concurrent chemoradiotherapy: three cycles of 100 mg/m² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy 3. Radiotherapy: radical intense modulated radiation therapy

Treatment:

Drug: Docetaxel, nedaplatin, fluorouracil

Drug: Nedaplatin

Radiation: Intensity modulated-radiotherapy

DPF-P

Active Comparator group

Description:

1. Induction chemotherapy: three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous cisplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks 2. Concurrent chemoradiotherapy: three cycles of 100 mg/m² cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy 3. Radiotherapy: radical intense modulated radiation therapy

Treatment:

Drug: Docetaxel, cisplatin, fluorouracil

Drug: Cisplatin

Radiation: Intensity modulated-radiotherapy