A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Guangxi Medical University

Status and phase: Unknown; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: nedaplatin and docetaxel; Drug: cisplatin and docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT01479504

GuangxiMU

Details and patient eligibility

About

This study is a multicenter trial.The primary objective is to estimate short-term efficacy and acute toxicities of nedaplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by nedaplatin in concurrent chemoradiotherapy, compared to cisplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by cisplatin in concurrent chemoradiotherapy for patients with locoregionally advanced nasopharyngeal carcinoma.

Secondary objectives are to evaluate the overall survival, the distant metastases free survival, and disease free survival of patients with locoregionally advanced nasopharyngeal carcinoma treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.

Full description

Patients with clinical stage T3-4N1/N2-3 (UICC 7th edition)are divided into two groups according to informed consent:intensity-modulated radiation therapy（IMRT）group and conventional fractionation radiotherapy(CRT)group. Then the patients in IMRT group/CRT group are randomly assigned to receive nedaplatin+docetaxel in neoadjuvant chemotherapy plus nedaplatin alone in concurrent chemoradiotherapy or cisplatin+docetaxel in neoadjuvant chemotherapy plus cisplatin alone in concurrent chemoradiotherapy.Evaluate the overall survival, the distant metastases free survival, and disease free survival of the patients treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.

Enrollment: 2 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically proven nasopharyngeal carcinoma for primary treatment with radical intent
• non-keratinizing or undifferentiated type
• clinical stage III-IVb (UICC 7th edition)
• age between 18-70
• satisfactory performance status: Karnofsky scale (KPS) > 70.
• hemoglobin > 100g/L, WBC > 4.0x10*9/L, Plt > 100x10*9/L
• serum creatinine level < 1.6 mg/dL or creatinine clearance ≥ 60 mL/min.
• normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤1.5ULN
• patients must be informed of the investigational nature of this study and give written informed consent.
• anticipated life span more than 6 month

Exclusion criteria

• primary treatment with palliative intent
• WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma Evidence of distant metastases
• pregnancy or lactation
• history of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
• prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
• prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years
• any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 4 patient groups

1A(nedaplatin and IMRT)

Experimental group

Description:

neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and Intensity-modulated Radiation Therapy(IMRT)

Treatment:

Drug: nedaplatin and docetaxel

Drug: nedaplatin and docetaxel

1B(cisplatin and IMRT)

Active Comparator group

Description:

neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and Intensity-modulated Radiation Therapy(IMRT)

Treatment:

Drug: cisplatin and docetaxel

Drug: cisplatin and docetaxel

2A(nedaplatin and CRT)

Experimental group

Description:

neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and conventional fractionation radiotherapy(CRT)

Treatment:

Drug: nedaplatin and docetaxel

Drug: nedaplatin and docetaxel

2B((cisplatin and CRT))

Active Comparator group

Description:

neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and conventional fractionation radiotherapy(CRT)

Treatment:

Drug: cisplatin and docetaxel

Drug: cisplatin and docetaxel