Nedaplatin in Treatment for Nasopharyngeal Carcinoma

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Status and phase: Completed; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Nedaplatin; Drug: Docetaxel, nedaplatin, fluorouracil; Radiation: IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT04834206

NPC-NDP-SGL arm

Details and patient eligibility

About

To evaluate the efficacy of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma.

Full description

This is a prospective, phase II clinical trial to evaluate the efficacy and safety of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma patients. This is a multicenter study. All patients will be enrolled in endemic area. All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is objective response rate (ORR).

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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
• 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 criteria

• Treatment with palliative intent
• The primary tumor or lymph node has undergone chemotherapy or surgery (except operations for diagnostic purposes)
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

DNF-N

Other 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:

Radiation: IMRT

Drug: Nedaplatin

Drug: Docetaxel, nedaplatin, fluorouracil