Clinical trial NCT01479504: A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Official title: A Multicenter Trial Evaluating the Efficacy and Safety of Nedaplatin Plus Docetaxel in Neoadjuvant Chemotherapy Followed by Nedaplatin in Concurrent Chemoradiation for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
neoadjuvant chemotherapy
concurrent chemoradiotherapy
Nedaplatin
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
Collaborators: name: People's Hospital of Guangxi Zhuang Autonomous Region
name: 303rd Hospital of the People's Liberation Army
name: Nanning Second People's Hospital
name: Guangxi Traditional Chinese Medical University
name: Guilin Medical College
name: Guangxi Naxishan Hospital
name: Liuzhou Workers Hospital
name: LiuZhou People's Hospital
name: Liuzhou Hospital of Traditional Chinese Medicine
name: Liuzhou Cancer Hospital
name: Liuzhou Railway hospital
name: First People's Hospital of Yulin
name: The Red Cross hospital of YuLin
name: Guigang People's Hospital
name: Wuzhou Red Cross Hospital
First posted: 2011-11-24
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: complete response (CR) rate
timeFrame: 3 months
Secondary outcomes:
measure: Acute toxicities
timeFrame: 2 years
measure: Overall Survival
timeFrame: 1,3,5 years
measure: cost-effectiveness ratio
timeFrame: 3 months
Other outcomes:
Locations:
city: Nanning
country: China
facility: Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
affiliation: Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University
name: Wang R. sheng, M.D.
role: STUDY_CHAIR
affiliation: Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University
name: Wang R sheng, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University
name: Wu Fang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: