A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Nasopharyngeal Carcinoma |
Drug: nedaplatin and docetaxel Drug: cisplatin and docetaxel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- complete response (CR) rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]3 months after treatment
- Acute toxicities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Acute toxicity will be measured by CTCAE3.0
- Overall Survival [ Time Frame: 1,3,5 years ] [ Designated as safety issue: No ]1 years，3 years and 5 years overall survival,disease free survival,distant metastases free survival
- cost-effectiveness ratio [ Time Frame: 3 months ] [ Designated as safety issue: No ]Calculate the cost(C) and complete response rate(E) of each group 3 months after treatment,then calculate cost-effectiveness ratio(C/E).
| Estimated Enrollment: | 2 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1A(nedaplatin and IMRT)
neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and Intensity-modulated Radiation Therapy(IMRT)
|
Drug: nedaplatin and docetaxel
neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy Other Name: TN
|
|
Active Comparator: 1B(cisplatin and IMRT)
neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and Intensity-modulated Radiation Therapy(IMRT)
|
Drug: cisplatin and docetaxel
neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy Other Name: TP
|
|
Experimental: 2A(nedaplatin and CRT)
neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and conventional fractionation radiotherapy(CRT)
|
Drug: nedaplatin and docetaxel
neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy Other Name: TN
|
|
Active Comparator: 2B((cisplatin and CRT))
neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and conventional fractionation radiotherapy(CRT)
|
Drug: cisplatin and docetaxel
neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy Other Name: TP
|
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01479504
| Contact: Wang R Sheng, M.D. | 86(0771)3276223 | wrsgx@yahoo.com.cn | |
| Contact: Wu Fang, M.D. | 86(0771)3276313 | 96160f@163.com |
| China, Guangxi | |
| Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University | Recruiting |
| Nanning, Guangxi, China, 530021 | |
| Contact: Wang R Sheng, M.D. 8613807806008 wrsgx@yahoo.com.cn | |
| Contact: Wu Fang, M.D. 8613978880156 96160f@163.com | |
| Principal Investigator: Wang R Sheng, M.D. | |
| Principal Investigator: Wu Fang, M.D. | |
| Study Chair: | Wang R. sheng, M.D. | Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University | |
| Principal Investigator: | Wang R sheng, M.D. | Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University | |
| Principal Investigator: | Wu Fang, M.D. | Department of Radiotherapy，the First Affiliated Hospital of Guangxi Medical University |
More Information
No publications provided
| Responsible Party: | Wang Rensheng, Director, Guangxi Medical University |
| ClinicalTrials.gov Identifier: | NCT01479504 History of Changes |
| Other Study ID Numbers: | GuangxiMU |
| Study First Received: | November 16, 2011 |
| Last Updated: | November 24, 2011 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Guangxi Medical University:
|
Nasopharyngeal Carcinoma neoadjuvant chemotherapy concurrent chemoradiotherapy Nedaplatin |
Additional relevant MeSH terms:
|
Pharyngeal Diseases Carcinoma Nasopharyngeal Neoplasms Head and Neck Neoplasms Nasopharyngeal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Neoplasms |
Stomatognathic Diseases Cisplatin Docetaxel Nedaplatin Antimitotic Agents Antineoplastic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators |
ClinicalTrials.gov processed this record on February 27, 2015