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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangxi Medical University
• Collaborators: 303rd Hospital of the People's Liberation Army; First People's Hospital of Yulin; Guangxi Naxishan Hospital; Guangxi Traditional Chinese Medical University; Guigang People's Hospital; Guilin Medical College; Liuzhou Cancer Hospital; Liuzhou Hospital of Traditional Chinese Medicine; LiuZhou People's Hospital; Liuzhou Railway hospital; Liuzhou Worker's Hospital; Liuzhou Workers Hospital; Nanning Second People's Hospital; People's Hospital of Guangxi; The Red Cross hospital of Wuzhou; The Red Cross hospital of YuLin; Wuzhou Red Cross Hospital
• Treatments: Cisplatin; Docetaxel; Nedaplatin

Criteria

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.